A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Metatstatic Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven unresectable locally recurrent or metastatic melanoma

- Chemotherapy naive with no more than 2 prior immunotherapy regimens (including
cytokines, vaccines, or adjuvant interferon) OR

- Prior chemotherapy failure with no more than 2 prior immunotherapy regimens
(including adjuvant interferon) and no more than 1 prior chemotherapy regimen
(which may include carmustine) not including antiangiogenesis therapy

- Measurable disease

- At least 20 mm in at least 1 dimension by conventional technique OR at least 10
mm in at least 1 dimension by spiral CT scan

- No disease confined only to the CNS

- No uncontrolled symptomatic brain metastases regardless of other disease sites

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,200/mm^3

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

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- AST and/or ALT no greater than 3 times upper limit of normal

- PT normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Pulmonary:

- DLCO at least 70% predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent significant psychiatric or medical illness, including active
infections, that would interfere with study therapy or increase risk

- No other malignancy within the past 5 years except curatively treated nonmelanomatous
skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer

PRIOR CONCURRENT THERAPY:

Chemotherapy:

- At least 4 weeks since prior systemic chemotherapy (at least 6 weeks since prior
carmustine or mitomycin) and recovered

- No other concurrent chemotherapy or investigational antineoplastic drugs

Radiotherapy:

- At least 2 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- At least 3 weeks since prior major surgery and recovered

Other:

- At least 4 weeks since other prior anticancer systemic therapy and recovered