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Clinical Trials at Tulane University Cancer Center

  • Posted: 09/16/2005

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Clinical Trials at Tulane University Cancer Center

A list of clinical trials organized by disease site is provided by Tulane University Cancer Center to help patients and physicians identify clinical trials in which they may have been participating prior to Hurricane Katrina. Links to NCI's PDQ® Clinical Trial Registry trial descriptions are included and can be used to identify alternate trial sites.

AIDS-Related Cancers
Brain
Breast
Gastro-intestinal
Genito-urinary
Gynecologic
Head and Neck
Leukemia
Liver
Lung
Lymphoma
Melanoma
Multiple Myeloma
Neuroblastoma
Soft Tissues Sarcoma
Hematopoietic Failure and Genetic Disease Transplant Studies
General protocols


AIDS-Related Cancers

AIDS-Associated Malignancies Clinical Trials Consortium (AMC)

AMC 036A Phase II Trial of Topical Halofuginone in Patients with HIV Related Kaposi's Sarcoma.


Brain

Tulane # LN01.1 IRB 10/11/01BRAIN (Metastases): Local therapy for limited metastatic disease to the brain: A Phase II study of surgery, SRS, and SRT in favorable patients.
* Tulane investigator-initiated study
COG # A9952
Closed
Chemotherapy for progressive low-grade astrocytoma in children younger than ten years old.
COG # P9934Systemic chemotherapy, second look surgery, and involved field radiation for children >= 8 months and <= 36 months with non-metastatic medulloblastoma.
RTOG # 04-20
IRB 03/15/2005
A Phase II study of radiation therapy plus low-dose Temozolomide followed by Temozolomide plus Irinotecan for glioblastoma multiforme.


Breast

NSABP # B-35
IRB 04/04/03
BREAST: A clinical trial comparing Anastrozole with Tamoxifen in post-menopausal patients with ductal carcinoma in situ (DCIS) undergoing lumpectomy with radiation therapy.
NSABP # B-36
IRB 07/28/2004
BREAST: A clinical trial of adjuvant therapy comparing six cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to four cycles of adriamycin and cyclophosphamide (AC), with or without Celecoxib, in patients with node-negative breast cancer.
NSABP # B-38
IRB 11/11/2004
BREAST: A Phase III adjuvant trial comparing three chemotherapy regimens in women with node-positive breast cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide followed by DD Paclitaxel (DD AC-->P); DD AC followed by DD Paclitaxel plus Gemcitabine (DD AC-->PG).
NSABP # P-2
(STaR)
IRB 5/10/99
Closed to accrual 09/2004
Study of Tamoxifen and Raloxifene (STaR) for the prevention of breast cancer. See further information on STaR trial.
NSABP # N01-AG-1-2106
(co-STAR)
IRB 12/20/01
Study of Tamoxifen and Raloxifene (STaR) for the prevention of breast cancer. See further information on STaR trial.
SWOG # S0221
IRB 02/29/2004
BREAST: Phase III trial of continuous schedule AC+G vs. Z 2-week schedule AC, followed by Paclitaxel given either every 2 weeks or weekly for 12 weeks as post-operative adjuvant therapy in node-positive or high-risk node negative breast cancer.
SWOG # S0338
IRB 01/13/2005
Temp. closure 04/15/2005
BREAST: A Phase II trial of Imatinib Mesylate (Gleevec) in combination with Capecitabine (Xeloda) in metastatic breast cancer.


Gastro-intestinal

Anal

RTOG # 03-15
IRB 07/20/2004
ANAL: A randomized, double-blind, placebo-controlled Phase III study to determine the efficacy of Sandostatin LAR (Ochtreotide Acetate) in preventing or reducing the Severity of chemoradiation-induced diarrhea in patients with anal or rectal cancer. Details on RTOG website in PDF format.

Colorectal

NSABP # C-08
IRB 10/04/2004
A Phase III clinical trial comparing infusional 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (mFOLFOX6) every two weeks with Bevacizumab to the same regimen without Bevacizumab for the treatment of patients with resected Stages II and III carcinoma of the colon.
NSABP # R-04
IRB 10/12/2004
A clinical trial comparing pre-operative radiation therapy and Capecitabine with pre-operative radiation therapy and continuous intravenous infusion (CVI) of 5-Fluorouracil (5-FU) in the treatment of patients with operable carcinoma of the rectum.

Esophageal Gall bladder

SWOG # S0202
Closed
A Phase II trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in patients with unresectable or metastatic gall bladder or cholangiocarcinoma.
SWOG # S0415
transplant
IRB 01/07/2005
Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II

Pancreas

TBC-PAN-003
IRB 08/16/2004
A Phase III randomized, controlled study to evaluate the safety and efficacy of PANVAC in combination with GM-CSF vs. best supportive care of palliative chemotherapy in patients with metastatic (Stage IV) adenocarcinoma of the pancreas who have failed a Gemcitabine-containing chemotherapy regimen.


Genito-urinary

Bladder

SWOG # 4B951
IRB 03/12/03
MVAC in organ-confined bladder cancer based on p53 status.

Prostate

SWOG # 9205
IRB 8/26/93
Companion to any SWOG PROSTATE CANCER study: Central Prostate Cancer Serum Repository
SWOG # S0000
IRB 8/9/01
Closed
June 2004
Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer, Phase III.
SWOG # S0000A
IRB 01/02/03
Prevention of Alzheimer's Disease with Vitamin E and Selenium (PREADVISE): Phase III ancillary to S0000-SELECT
SWOG # P9346
IRB 10/26/95
PROSTATE: (Stage IV) Induction: Flutamide + luprondepotor) zoladex). Consolidation: continuous androgen deprivation vsl. intermittent androgen deprivation.
SWOG # S9917
IRB 7/12/01
PROSTATE: (Prevention): "L-Selenium-based chemoprevention of prostate cancer among men with high-grade prostatic intraepithelial neoplasis"
SWOG # S9921
IRB 1/10/00
PROSTATE: Adjuvant androgen deprivation versus Mitoxantrone plus Prednisone plus androgen deprivation in selected high risk prostate cancer patients following radical prostatectomy, phase III
SWOG # JPR.3
IRB 12/12/96
PROSTATE: (T3-4, N0, M0) Phase III comparing total androgen blockade vs. total androgen blockade + pelvic irradiation.
SWOG # JPR.7
IRB 12/28/99
PROSTATE: Intergroup phase III randomized trial comparing intermittent vs. continuous androgen suppression for patients with prostate-specific-antigen progression in the clinical absence of distant metastases following radiotherapy for prostate cancer

Kidney (Renal)

COG # NWTSG 4941
Closed
WILMS' TUMOR: National Wilms' Tumor study V. Therapeutic trial and biology study
COG # NWTSG 4942
Closed
WILMS' TUMOR: Treatment of relapsed patients. A national Wilms Tumor study group Phase III study.


Gynecologic

Cervical

GOG # 179
Closed
IRB ok 11/6/00
CERVICAL: (Stage IVB) A randomized Phase III study of Cisplatin vs. Cisplatin plus Topotecan vs. MVAC in Stage IVB, recurrent or persistent carcinoma of the cervix.
GOG # 191
Closed
CERVICAL: (Stage IIB, IIIB, IVA) A Phase III trial to evaluate the efficacy of maintaining hemoglobin levels above 120 G/L with erithropoietin vs. above 100 G/L without erithropoietin in anemic patients receiving concurrent radiation and cisplatin and cervical cancer.

Endometrial

GOG # 137
Closed
ENDOMETRIAL: (Stage I, II) A randomized double-blinded trial of estrogen replacement therapy vs. placebo in women with Stage I or II endometrial adenocarcinoma.
GOG # 184
Closed
ENDOMETRIAL: A randomized Phase III study of tumor volume-directed pelvic +/- para-aortic irradiation followed by Cisplatin and Doxorubicin or Cisplatin, Doxirubicin and Paclitaxel for advanced endometrial carcinoma.

Ovarian

# C0307OVARIAN: A Phase I/II trial of intravenous Ontak to treat epithelial ovarian cancer FIGO Stage III or Stage IV, or extraovarian peritoneal carcinoma, failing or ineligible for first-line therapy. A Tulane-initiated study.
GOG # 136OVARIAN: (All stages): Acquisition of human gynecological specimens and serum to be used in studying the causes, diagnosis, prevention and treatment of cancer.
GOG # 175OVARIAN: (Early stage): 175mg/m2 q 21 days x 3 courses plus low dose Paclitaxel 40 mg/m3/wk vs. IV Carboplatin (AUC6) and Paclitaxel 174mg/m2 q 21 days x 3 courses plus observation in patient with early stage ovarian carcinoma.
GOG # 182OVARIAN: (Stage III, IV): A Phase III randomized trial of Paclitaxel and Carboplatin vs. triplet or sequential doublet combinations in patients with epithelial ovarian carcinoma or primary peritoneal carcinoma.
GOG # 199OVARIAN: A prospective study of risk-reducing salpingo-oophorectomy and longitudinal CA-125 screening among women at increased genetic risk of ovarian cancer.

Sarcoma

GOG # 161SARCOMA: A phase III trial of Ifosfamide (NSC#109724) versus Ifosfamide plus Paclitaxel (NSC#125973) in patients with advanced, persistent, or recurrent carcinosarcoma (mixed mesodermal tumors) of the uterus).

Trophoblastic Neoplasia

GOG # 174
IRB 6/14/99
LOW-RISK: A randomized Phase III trial of weekly parenteral methotrexate vs. 'pulsed' dactinomycin as primary management for low-risk gestational trophoblastic neoplasia.
GOG # 176
Closed
IRB 10/18/99
FAILED LOW-RISK: A Phase II trial of pulse Acgtinomycin-D as salvage therapy for failed low-risk gestational trophoblastic neoplasia


Head and Neck

RTOG # 0225
IRB 05/28/2003
A Phase II study of intensity-modulated radiation therapy (IMRT) +/- chemotherapy for nasopharyngeal cancer.
RTOG # 0234A Phase II randomized trial of surgery followed by chemoradiotherapy plus c225 (Cetuximab) for advanced squamous cell carcinoma of the head and neck.

Details on RTOG website in PDF format.


Leukemia

General

SWOG # 9007
IRB 9/12/91
Companion to any SWOG LEUKEMIA study: Cytogenetics (marrow)

Acute Leukemia

SWOG # 9910
IRB 2/17/00
ANCILLARY: Leukemia centralized reference laboratories and tissue repositories
SWOG # S0301
IRB 03/11/2004
A Phase II study of induction with Daunorubicin, Cytarabine, and Cyclosporine all by continuous IV infusion for previously untreated non-M3 acute myeloid leuemia (AML) in patients age 56 or older. Temporary closure as of March 2004.
SWOG # S0432
IRB 01/07/2005
A Phase II study of two different schedules and two different doses of the farnesyl transferase inhibitor R115777 (Tipifarnib, Zarnestra, NSC-702818) for previously untreated acute myeloid leukemia (AML) in patients age 70 or older.
Tulane BMT # 98-1 IRB 11/10/98TRANSPLANT: Bone marrow transplant for high-risk LEUKEMIAS with busulfan, CTX, and Etoposide
* Tulane investigator-initiated study

Chronic Leukemia

BMT # 2000-01 IRB 1/25/00CML in the first chronic phase. Allogeneic BMT for chronic myelogenous leukemia using primed bone marrow stem cells.
*Tulane investigator-initiated study.

COG Leukemia studies

COG # P9407Induction intensification and allogeneic bone marrow transplant in infant ALL: A COG pilot study.
COG # P9900

ALinC17: Leukemia cell classification protocol
COG # P9904ALinC17: Treatment for patients with low-risk acute lymphoblastic leukemia
Temporary closure
COG # P9905
Closed
ALinC17: Protocol for patients with newly-diagnosed standard-risk acute lymphoblastic leukemia (ALL).
COG # P9907ALinC17: Cytogenetics protocol
COG # AALL0031Pilot study for the treatment of very-high-risk acute lymphoblastic leukemia (ALL) in children and adolescents (ST1571 NSC#716051/IND#61135). Phase III group-wide pilot study.
COG # ADVL0022Phase II study of Gemcitabine in children with relapsed acute lymphoblastic leukemia or acute myelogenous leukemia (AML)
COG # ADVL0023Phase II study of Docetaxel (Taxotere) (NSC#628503) in children with refractory leukemias
COG # ADVL0122
Closed
Phase II trial of Gleevec (Imatinib Mesylate, formerly ST1571) in children with refractory or relapsed solid tumors.
COG # AS9801ANCILLARY: Second malignant neoplasms following childhood cancer.
COG # DFCI ALL 2000-01Dana Farber Cancer Institute (DFCI) ALL Consortium Protocol 2000-01: Treatment of acute lymphoblastic leukemia (ALL) in children, both high-risk and standard-risk. Submitted to IRB.


Liver

# COM 02-721
IRB 11/17/2003
Multi-institution Phase I/II dose escalation study of body stereotactic hypofractionated radiation therapy for liver metastases.
# MB 04-01
IRB 11/12/2004
Phase II study of arsenic trioxide in combination with ascorbic acid in hepatocellular carcinoma.
NSABP # CI-66
Closed
IRB 01/15/2004
A Phase II trial evaluating multiple metastatectomy combined with hepatic artery infusion of Floxuridine (FUDR) and Dexamethasone (DXM), alternating with systemic Oxaliplatin (OXAL) and Capecitabine (CAPCIT) for colorectal carcinoma metastatic to the liver.
Closed to accrual.
COG # P9346Hepatoblastoma biology study and tissue bank
COG # P9645Phase III intergroup protocol for the treatment of children with hepatoblastoma.


Lung

SWOG # S9925
IRB 03/14/02
Lung cancer specimen repository protocol.
SWOG # S0310
IRB 06/09/2004
Closed
Phase II trial of CG8123, an autologous cancer vaccine (GVAX) in patients with Stage IIIB and IV bronchiloaveolar carcinoma (BAC)
SWOG # S0124
IRB 05/16/2003
Randomized Phase III trial of Cisplatin and Irinotecan (NSC-616348) vs. Cisplatin and Etoposide in patients with extensive stage small-cell lung cancer (E-SCLC)

Non-small-cell Lung

SWOG # E5597
IRB 6/14/01
(Post-op, Stage IA, pT1N0 or Stage IB, pT1N0) "Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small-Cell Lung Cancer"
SWOG # S0342
IRB 01/07/2005
Closed
Phase II selection design trial of concurrent chemotherapy + Cetuximab vs. chemotherapy followed by Cetuximab in advanced non-small cell lung cancer (NSCLC)
RTOG # 0236A Phase II trial of stereotactic body radiation therapy (SBRT) in the treatment of patients with medically inoperable Stage I/II non-small cell lung cancer. Details on RTOG website in PDF format.

Small-cell Lung: None currently open


Lymphoma

Hodgkin's Lymphoma

SWOG # E2496
IRB 12/31/99
Randomized phase III trial of ABVD versus Stanford v +/- radiation therapy in locally extensive and advanced stage Hodgkin's disease with 0-2 risk factors.
COG # AHOD0031Phase III group-wide study of dose-intensive response-based chemotherapy and radiation therapy for children and adolescents with newly-diagnosed intermediate-risk Hodgkin's disease.
COG # AHOD00P1A pilot study of re-induction chemotherapy with Ifosfamide and Vinorelbine (IV) in children with refractory/relapsed Hodgkin's Disease

Non-Hodgkin's Lymphoma

SWOG # 8819
transplant
IRB 10/11/90
Companion to 9320, 9703, 9704, 9800 (Non-Hodgkin's Lymphoma): Central lymphoma repository tissue procurement.
SWOG # S9704
IRB 12/29/97
Non-Hodgkin's Lymphoma (diffuse, aggressive, intermediate & high risk): Phase III trial comparing early high dose chemoradiotherapy (4 cycles CHOP) + autologous stem cell transplant to 8 cycles CHOP. (Temporary Closure 5/15/99)
Tulane BMT #
99-2
IRB 2/24/00
Autologous transplantation for non-Hodgkin's lymphoma. The role of in vivo purging with monoclonal antibody.
COG # A5971A randomized Phase III study for the treatment of newly-diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma.

AIDS-related Non-Hodgkin's Lymphoma

SWOG # 8947
IRB 5/10/90
Companion to SWOG S9704: Central serum repository (mandatory)
SWOG # 9245 IRB 05/13/93Companion to SWOG S9704: Central lymphoma repository tissue procurement protocol for relapsed or recurrent disease (optional)

T-cell Lymphoma

 Phase II Study- Arsenic Trioxide in Patients with Cutaneous T-Cell Lymphoma (CTI)


Melanoma

None currently open.


Multiple Myeloma

Tulane BMT # 99-1
IRB 08/02/99
MULTIPLE MYELOMA: Immuno-transplantation for lymphoid malignancy using allogeneic blood stem cells.
Tulane # HSO1.02
IRB 3/12/02
MULTIPLE MYELOMA: Autologous peripheral stem cell transplantation for multiple myeloma: Safety and efficacy of the use of Rituxan for in vivo purging prior to high-dose chemotherapy and peripheral stem cell transplantation in the treatment of multiple myeloma. * Tulane investigator-initiated.
SWOG # S0115
transplant
IRB 07/15/2004
A Phase II trial evaluating modified high-dose Melphalan (100 mg/m2) and autologous peripheral blood stem cell supported transplantation (SCT) for high-risk patients with multiple myeloma and/or light chain amyloidosis. BMT
SWOG # S0309
transplant
IRB 07/15/2004
Myeloma specimen repository protocol, ancillary.
MAC 001
IRB 07/29/2004
A prospective, open-label, safety and efficacy study of combination treatment with Melphalan, Arsenic Trioxide acid in patients with relapsed or refractory myeloma.


Neuroblastoma

COG # A3961Treatment for infants and children with intermediate risk neuroblastoma.
COG # A3973A randomized study of purged vs. unpurged PBSC transplant following dose-intensive induction therapy for high-risk NBL.
COG # ANBL00B1Neuroblastoma biology studies.
COG # P9641
Closed
Primary surgical therapy for biologically defined low-risk neuroblastoma.


Soft Tissue Sarcoma

AMC # #036
IRB 07/07/2003
A randomized Phase II trial of topical Halofuginone in patients with HIV-related Kaposi's sarcoma.
RTOG # 03-30
IRB 09/20/2004
A pilot Phase II study of pre-operative radiation therapy and thalidomide (IND 48832; NSC 66847) for low-grade primary soft tissue sarcoma or pre-operative Maid/Thalidomide/radiation therapy for high/intermediate-grade primary soft tissue sarcoma of the extremity or body wall. Details on RTOG website in PDF format.
COG # AEWS0031EWINGS SARCOMA: Trial of chemotherapy intensification through interval compression in Ewing's Sarcoma and related tumors
COG # AOST0121OSTEOGENIC SARCOMA: A group-wide Phase II study of Trastuzumab (Herceptin) in metastatic osteosarcoma patients with tumors that over-express HER2.
COG # P9851OSTEOGENIC SARCOMA: Biology studies in osteosarcoma: Companion study to intergroup therapeutic.
COG # IRSG D9602
Closed
RHABDOMYOSARCOMA: Actinomycin D & Vincristine with or without radiation therapy for newly-diagnosed patients with low-risk embryonal/botryoid rhabdomyosarcoma or undifferentiated sarcoma: An IRS-V protocol.
COG # IRSG D9802RHABDOMYOSARCOMA: A Phase II study of Irinotecan (CPT-11) combined with vincristine followed by multimodal, multi-agent therapy for selected children and adolescents with newly-diagnosed stage IV/clinical group IV rhabdomyosarcoma. An IRS-V protocol.
COG # IRSG D9803
Temporarily Closed to Accrual
RHABDOMYOSARCOMA: Randomized study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) vs. VAC alternating with Vincristine, Topotecan, and Cyclophosphamide for patients with intermediate-risk rhabdomyosarcoma
COG # ARST 0121RHABDOMYOSARCOMA: A groupwide protocol for collecting and banking pediatric cancer research specimens. An intergroup rhabdomyosarcoma study group protocol.
COG # ARST 0121RHABDOMYOSARCOMA: Group-wide randomized Phase II window study of two different schedules of Irinotecan in combination with Vincristine and pilot assessment of safety and efficacy of Tirapazamine combined with multi-agent chemotherapy for first relapse or progressive disease in rhabdomyosacroma and related tumors.


Hematopoietic Failure and Genetic Disease Transplant Studies

Tulane BMT # 2001-01
IRB 2/8/2001
G-CSF primed donor leukocyte infusion (G-DLI) for treatment of relapsed hematologic malignancy after allogeneic stem cell transplant.
Tulane BMT # 2001-03
IRB 7/17/2001
Phase II trial of CD34 selected peripheral blood progenitor cells with immunoablation in the treatment of severe autoimmune disease
Tulane # TC01.1
IRB 10/30/01
(DC1s and DC2s) Dendritic cells in hematologic malignancies.
* Tulane investigator-initiated study
Tulane # TC01.2
IRB 07/17/02
Evaluation of the immunologic consequences of circulating nucleated red blood cells
* Tulane investigator-initiated study


General protocols

Tulane # TC01.3
IRB 10/01/2003
Phase I/II dose escalation trial of intravenous Ontak to enhance tumor immunity in patients with cancer.
* Tulane investigator-initiated study
RTOG # 03-15
IRB 07/20/2004
A randomized, double-blind, placebo-controlled Phase III study to determine the efficacy of Sandostatin LAR (Ochtreotide Acetate) in preventing or reducing the Severity of chemoradiation-induced diarrhea in patients with anal or rectal cancer.
Details on RTOG website in PDF format.

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