Temozolomide Plus PEG-Interferon Alfa-2B in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PEG-interferon alfa-2B may interfere with the growth of cancer cells. Combining temozolomide with PEG-interferon alfa-2B may be an effective treatment for advanced solid tumors.

PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and PEG-interferon alfa-2B in treating patients who have advanced solid tumors.

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

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced solid tumor that is refractory to standard therapy OR

• Histologically confirmed chemotherapy-naive advanced cancer for which no curative therapy or higher priority palliative chemotherapy exists

• Brain metastasis allowed

• No bone marrow involvement of tumor

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3 AND/OR

• Platelet count greater than 100,000/mm^3

Hepatic:

• ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

• No autoimmune hepatitis

Renal:

• Creatinine less than 2.5 times ULN

Cardiovascular:

• No severe coronary artery disease

• No congestive heart failure

Pulmonary:

• No severe chronic obstructive pulmonary disease

Gastrointestinal:

• No frequent vomiting

• No medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction, partial intestinal bypass, or external biliary diversion)

Other:

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No known or suspected hypersensitivity to imidazotetrazin, interferon alfa, or any excipient or vehicle included in the formulation or delivery system of study drug

• No history of autoimmune disease

• No preexisting severe psychiatric condition or history of severe psychiatric disorder (including suicidal ideation or attempt)

• No life-threatening condition or severe preexisting condition

• No uncontrolled thyroid abnormalities

• No nonmalignant systemic disease

• No active uncontrolled infection

• HIV negative

• No AIDS-related illness

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic agents (e.g., bi-specific antibodies, interleukin-2, or interferon) and recovered (excluding alopecia)

• No prior allogeneic, syngeneic, or autologous bone marrow or stem cell transplantation

• No other concurrent biologic therapy

• No concurrent colony stimulating factors or epoetin alfa for the prevention of myelotoxicity

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (more than 6 weeks for nitrosoureas, melphalan, or mitomycin) and recovered (excluding alopecia)

• No prior high-dose chemotherapy and stem cell transplantation

• No more than 3 prior chemotherapy regimens

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 6 weeks since prior wide-field radiotherapy to at least 25% of bone marrow (e.g., pelvic radiotherapy)

• More than 6 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium

• Recovered from prior radiotherapy (excluding alopecia)

• No concurrent radiotherapy

Surgery:

• At least 4 weeks since prior major surgery

• At least 1 week since prior minor surgery

Other:

• At least 4 weeks since prior investigational therapy