VNP40101M in Treating Patients With Advanced or Metastatic Cancer

• Status: Completed
• Trial end date: 2008-01-01
• 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 or metastatic cancer.

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

Details

• Lead Sponsor: Vion Pharmaceuticals

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

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 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

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