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

Alternate Title

EMD 121974 in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	UCHSC-001096 NCI-3358, 3358, NCT00022113

Objectives

1. Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors.
2. Determine the biologic activity of this drug in these patients.
3. Determine the pharmacokinetic profile and plasma biological effects of this drug and identify any relationship with its biologic activity or observed toxicity in these patients.
4. Determine, preliminarily, the antitumor efficacy of this drug in these patients.

Entry Criteria

Disease Characteristics:

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



• Tumors must be amenable to minimally-invasive biopsy (i.e., tumors must be superficial enough to be sampled by punch biopsy or core biopsy procedure without radiologic guidance)*

   [Note: *For at least 6 patients per cohort]




• No uncontrolled brain metastases, including symptomatic lesions or lesions requiring glucocorticoids and/or anticonvulsants to suppress symptoms
  • Negative brain scan required if there are signs and symptoms suggestive of brain metastasis

Prior/Concurrent Therapy:

Biologic therapy:

• No other concurrent anticancer immunotherapy
• Concurrent hematologic growth factors for cytopenias allowed

Chemotherapy:

• At least 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin) and recovered

Endocrine therapy:

• See Disease Characteristics
• No concurrent anticancer hormonal therapy
• Concurrent oral contraceptives or postmenopausal hormone replacement allowed

Radiotherapy:

• Recovered from prior radiotherapy
• At least 2 weeks since prior palliative radiotherapy to bone or brain metastases
• At least 4 weeks since prior anticancer radiotherapy
• No concurrent anticancer radiotherapy

Surgery:

• Not specified

Other:

• At least 4 weeks since prior anticancer therapy and recovered
• At least 4 weeks since prior investigational agents
• Any number of prior therapies allowed
• No other concurrent anticancer investigational or commercial agents
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin normal
• AST and ALT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris

Other:

• No ongoing or active infection
• No other concurrent serious systemic disorders (e.g., significant CNS illness) that would preclude study
• No concurrent psychiatric illness or social situations that would preclude study
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 10-35 patients will be accrued for this study within 12-18 months.

Outline

This is a dose-escalation study.

Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-10 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Trial Contact Information

Trial Lead Organizations

University of Colorado Cancer Center at UC Health Sciences Center

Michele Basche, MD, Principal investigator		Ph: 720-848-0449

Registry Information
Official Title		A Phase I Study of EMD 121974 in Patients with Advanced Solid Tumors
Trial Start Date		2002-05-14
Registered in ClinicalTrials.gov		NCT00022113
Date Submitted to PDQ		2001-06-07
Information Last Verified		2003-12-08
NCI Grant/Contract Number		P30-CA46934

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