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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the safety and tolerability of temozolomide and PEG-interferon alfa-2b in patients with advanced refractory solid tumors or chemotherapy-naive advanced cancer. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity of this regimen in this patient population. Determine the pharmacokinetics of PEG-interferon alfa-2b at the MTD when administered with temozolomide in this patient population. Determine the anti-tumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral temozolomide on days 1-7 and 15-21 and PEG-interferon alfa-2b subcutaneously on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-9 patients receive escalating doses of temozolomide and PEG-interferon alfa-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.

Official Title
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A Phase-I Study Of Cyclical Oral Administration Of Temozolomide In Combination With PEG12000-Interferon Alfa-2B In Patients With Refractory And/Or Advanced Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: PEG-interferon alfa-2b
* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: PEG-interferon alfa-2b|nan|
|Drug: temozolomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific