VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced solid tumors or lymphomas.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vion Pharmaceuticals

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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• At least 3 months

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• 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 FEV_1 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)

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)