Clinical trial · Interventional
Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Intravenous CCI-779 Given in Combination With Escalating Doses of Interferon-Alpha to Patients With Advanced Renal Cancer
- 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. Biological therapies such as interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological therapy in treating patients who have locally advanced or metastatic kidney cancer.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| temsirolimus | Drug | Temsirolimus | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed locally advanced or metastatic renal cell cancer * Progressive disease after treatment with 0-2 courses of immunotherapy, chemotherapy, or other systemic therapy for advanced disease * Measurable or evaluable disease * No concurrent CNS metastases * Prior CNS metastases allowed if no residual disease by MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal * Creatinine less than 2 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular * No unstable angina * No myocardial infarction within the past 6 months Other * Cholesterol no greater than 350 mg/dL * Triglycerides no greater than 400 mg/dL * HIV negative * Not immunocompromised * No active autoimmune disorder * No active infection requiring antibiotic therapy * No other serious concurrent illness * No known hypersensitivity to components of CCI-779, interferon alfa, diphenhydramine hydrochloride, or both acetaminophen and nonsteroidal anti- inflammatory drugs * No other major illness that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 3 weeks since prior immunotherapy * No prior interferon alfa * No other concurrent immunotherapy * No prophylactic growth factors * Concurrent epoetin alfa allowed Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy * No prior CCI-779 * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy for malignancy (megestrol for appetite loss allowed) * Concurrent inhaled or replacement steroids allowed Radiotherapy * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 3 weeks since prior surgery Other * See Disease Characteristics * At least 3 weeks since prior immunosuppressive agents * At least 4 weeks since prior investigational agents * No other concurrent investigational agents * No concurrent immunosuppressive therapy * No concurrent anticonvulsants known to be cytochrome P450 inducers, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide * No concurrent maintenance therapy for life-threatening ventricular arrhythmia
References
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