Clinical trial · Interventional
Temozolomide Plus PEG-Interferon Alfa-2B in Treating Patients With Advanced Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available