A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer

Inclusion 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