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

Alternate Title

VNP40101M in Treating Patients With Advanced or Metastatic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Pharmaceutical / Industry	VION-CLI-028 YALE-HIC-16775, NCT00049699

Objectives

1. Determine the toxic effects of VNP40101M in patients with advanced or metastatic solid tumor or lymphoma.
2. Determine the maximum tolerated dose of this drug in these patients.
3. Determine the pharmacokinetics of this drug in these patients.
4. Determine the antitumor effects of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed advanced or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists



• Measurable or evaluable disease



• Primary brain tumors or brain metastases allowed provided neurologic deficits are stable and do not preclude study compliance

Prior/Concurrent Therapy:

Biologic therapy

• Recovered from acute toxicities of prior biologic therapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)

Chemotherapy

• More than 6 months since prior high-dose chemotherapy with stem cell support
• More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas)
• Recovered from acute toxicities of prior chemotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)

Endocrine therapy

• At least 2 weeks since prior hormonal therapy

Radiotherapy

• Recovered from acute toxicities of prior radiotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)

Surgery

• At least 2 weeks since prior surgery

Other

• No other concurrent standard or investigational treatment for cancer
• No concurrent disulfiram

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 3 months

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hematocrit at least 30% (transfusion allowed)
• No bleeding diathesis

Hepatic

• PT and PTT no greater than 1.5 times the upper limit of normal (ULN)
• Bilirubin no greater than 1.5 times ULN
• ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
• Albumin at least 2.5 gm/dL

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• At least 3 months since prior myocardial infarction
• No symptomatic coronary artery disease
• No arrhythmias requiring medication
• No uncontrolled congestive heart failure

Pulmonary

• No dyspnea on minimal or moderate exertion
• DLCO and FEV1 at least 60% predicted

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled active bleeding (e.g., active peptic ulcer disease)
• No active infection
• HIV negative

Expected Enrollment

Approximately 20 patients will be accrued for this study.

Outline

This is a dose-escalation study.

Patients receive VNP40101M IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 28 days.

Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose is determined.

Trial Contact Information

Trial Lead Organizations

Vion Pharmaceuticals, Incorporated

Mario Sznol, MD, Protocol chair		Ph: 203-498-4210

Registry Information
Official Title		A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients with Advanced or Metastatic Cancer
Trial Start Date		2002-10-15
Registered in ClinicalTrials.gov		NCT00049699
Date Submitted to PDQ		2002-10-09
Information Last Verified		2004-03-31

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