Expired Study
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Lebanon, New Hampshire 03756


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00014261


Primary Contact:

Study Chair
Lionel D. Lewis, MD
Norris Cotton Cancer Center


Backup Contact:

N/A


Location Contact:

Lebanon, New Hampshire 03756
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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