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

Alternate Title

VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Pharmaceutical / Industry	VION-CLI-011 NCI-V01-1669, NCT00025129

Objectives

1. Determine the maximum tolerated dose of VNP40101M in patients with advanced solid tumors or lymphomas.
2. Determine the toxic effects of this drug in these patients.
3. Determine the pharmacokinetics of this drug in these patients.
4. Determine the anti-tumor effects of this drug in these patients.

Entry Criteria

Disease Characteristics:

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



• Measurable or evaluable metastatic disease



• No other hematologic malignancy



• No large pleural, pericardial, or peritoneal effusions



• No requirement for immediate palliative treatment, including surgery



• No symptomatic brain metastases or metastases with substantial edema
  • Asymptomatic brain metastases or primary CNS disease allowed if neurologic deficits are stable

Prior/Concurrent Therapy:

Biologic therapy:

• At least 3 weeks since prior biologic agents and recovered
• At least 6 months since prior high-dose chemotherapy regimen with stem cell support

Chemotherapy:

• See Biologic therapy
• At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

• At least 2 weeks since prior hormonal therapy and recovered

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics
• At least 2 weeks since prior surgery and recovered

Other:

• No other concurrent standard therapy for cancer
• No other concurrent investigational agents
• No concurrent disulfiram (Antabuse)

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 active uncontrolled bleeding

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
• Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver or bone metastases present)
• PT and aPTT no greater than 1.5 times ULN
• Albumin at least 2.5 g/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• Ejection fraction at least 45%
• No active heart disease
• No myocardial infarction within the past 3 months
• No symptomatic coronary artery disease
• No arrhythmias requiring medication
• No uncontrolled congestive heart failure

Pulmonary:

• DLCO and FEV₁ at least 60% of predicted
• No dyspnea with minimal to moderate exertion

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• HIV negative
• No active infection
• Persistent stable chronic toxic effects from prior therapy allowed if no greater than grade 1
• No bleeding diathesis (e.g., active peptic ulcer disease)

Expected Enrollment

Approximately 20-30 patients will be accrued for this study.

Outline

This is a dose-escalation study.

Patients receive VNP40101M IV over 15 minutes on day 1. Treatment repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

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 VNP4010M, A Novel Alkylating Agent for Patients with Advanced or Metastatic Cancer
Trial Start Date		2001-03-27
Registered in ClinicalTrials.gov		NCT00025129
Date Submitted to PDQ		2001-07-30
Information Last Verified		2004-03-31

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