Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	AECM-1199906196 HYBRIDON-231-100B, NCI-G00-1665, NCT00004863

Objectives

I. Determine the safety and maximum tolerated dose of GEM 231 and paclitaxel 
in patients with recurrent or refractory solid tumors.

II. Determine any preliminary antitumor activity of this regimen in these 
patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed advanced solid tumor that is refractory to standard
therapy or for which no standard therapy exists

Measurable or evaluable disease

No CNS metastases that are untreated, associated with seizures, or require
intravenous medication and/or hospitalization

Prior/Concurrent Therapy:

Biologic therapy:
 At least 1 week since prior transfusion
 Prior biologic therapy allowed and recovered
 No concurrent biologic therapy

Chemotherapy:
 Prior chemotherapy allowed and recovered
 No other concurrent chemotherapy

Endocrine therapy:
 Prior hormonal therapy allowed and recovered
 Concurrent palliative hormonal therapy allowed

Radiotherapy:
 Prior radiotherapy allowed and recovered
 No concurrent radiotherapy (except palliative)

Surgery:
 At least 2 weeks since prior major surgery with wound complications

Other:
 At least 2 weeks since prior investigational drugs
 No other investigational drugs during or within 28 days of study
 No concurrent CYP-3A metabolism dependent drugs

Patient Characteristics:

Age:
 18 and over

Performance status:
 WHO 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Absolute neutrophil count at least 1,500/mm3
 Platelet count at least 100,000/mm3
 Hemoglobin at least 8.5 g/dL

Hepatic:
 Bilirubin no greater than upper limit of normal (ULN), except with Gilbert's
  syndrome (no greater than 1.5 times ULN if liver metastases present)
 PT and aPTT normal
 SGOT or SGPT less than 3 times ULN (no greater than 5 times ULN if liver
  metastases present)

Renal:
 Creatinine less than 1.25 times ULN
 No renal tubular dysfunction (i.e., at least 2+ proteinuria within the past 2
  weeks)

Other:
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception for 1 month prior to,
  during, and 3 months after study
 No other serious medical condition that would prevent compliance
 No serious infection
 No known hypersensitivity to paclitaxel or other drugs formulated in
  Cremophor or any oligodeoxynucleotides
 Adequate venous access
 No psychological or geographical condition that would prevent compliance

Expected Enrollment

A maximum of 1 patient will be accrued per week for this study until the 
maximum tolerated dose is reached.

Outline

This is a dose escalation study of GEM 231.

Patients receive paclitaxel IV over 3 hours on day 1, immediately followed by 
GEM 231 over 2 hours on days 1, 4, 8, 11, 15, and 18. Treatment continues 
every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients are treated with one of two doses of paclitaxel and 
escalating doses of GEM 231 until the maximum tolerated dose (MTD) is 
determined. The MTD is defined as the dose at which no more than 2 of 6 
patients experience dose limiting toxicity.

Patients are followed monthly for 3 months.

Trial Contact Information

Trial Lead Organizations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Sridhar Mani, MD, Protocol chair		Ph: 718-904-2488 Email: smani@montefiore.org

Registry Information
Official Title		A Phase I Open-Label Safety Study of Escalating Doses of Taxol in Combination with Escalating Doses of GEM231 in Patients with Refractory Solid Tumors
Trial Start Date		1999-07-01
Registered in ClinicalTrials.gov		NCT00004863
Date Submitted to PDQ		2000-01-04
Information Last Verified		2008-07-09
NCI Grant/Contract Number		CA13330

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