OBJECTIVES:

• Determine the maximum tolerated dose and dose-limiting toxicity of oblimersen and gemcitabine in patients with advanced solid tumor or lymphoma.
• Determine the effect of oblimersen on the pharmacokinetics and pharmacodynamics of gemcitabine in these patients.
• Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on day 5. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oblimersen and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients receive treatment at the MTD.

PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study within 6-8 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed malignancy for which there is no standard or effective curative or palliative therapy

  • Solid tumors and lymphoma allowed
  • Metastatic or unresectable disease

• Measurable or evaluable nonmeasurable disease

  • Evaluable nonmeasurable disease includes ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses not followed by CT scan or MRI, or cystic lesions
  • Disease characterized by elevated serum tumor marker alone is allowed
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 2.5 times upper limit of normal
• No history of portal hypertension
• No history of cirrhosis or hepatitis
• No radiographic evidence of cirrhosis and/or varices

Renal

• Creatinine normal OR
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to oblimersen or other study agents
• No other concurrent uncontrolled illness that would preclude study participation
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent prophylactic colony-stimulating factors such as filgrastim (G-CSF) or sargramostim (GM-CSF)

• Concurrent interventional growth factors allowed

  • No growth factor administration within 24 hours before study chemotherapy
• Concurrent epoetin alfa allowed

Chemotherapy

• No more than 3 prior chemotherapy regimens
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• More than 2 weeks since prior hormonal therapy
• Concurrent megestrol for anorexia/cachexia allowed

Radiotherapy

• No prior pelvic or whole abdominal radiotherapy
• More than 4 weeks since prior radiotherapy

Surgery

• More than 4 weeks since prior major surgery

Other

• Recovered from prior therapy
• More than 4 weeks since prior investigational therapy
• No prior oblimersen
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients