Clinical trial · Interventional
Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
NCT00003656CI-TRIAL-00057215completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have 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 |
| tretinoin liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All subjects
- description
- Weekly ATRA-IV with recombinant interferon alfa
- interventionNames
- Biological: recombinant interferon alfa
- Drug: tretinoin liposome
Primary outcomes (2)
- measure
- Best Response as Measured by CT, Bone Scans, and Clinical Progression
- timeFrame
- After 8 weeks
- measure
- Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
- timeFrame
- In 30 days after the last dose, an average of 1 year.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * Bidimensionally measurable disease * No active brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * No coagulation disorders Hepatic: * Bilirubin less than 1.5 mg/dL * SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal * No clinically significant hepatic disease, including autoimmune hepatitis Renal: * Creatinine less than 2 mg/dL OR * Creatinine clearance greater than 50 mL/min * No clinically significant renal disease Cardiovascular: * No clinically significant cardiac disease * No thrombophlebitis Pulmonary: * No severe debilitating pulmonary disease * No pulmonary embolism Other: * No history of diabetes mellitus prone to ketoacidosis * No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study * No thyroid abnormalities that hinder maintaining thyroid function at the normal range * No severe infection * No severe malnutrition * No clinically significant retinal abnormalities * No pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder * No other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective methods of contraception during and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior biological response modifier therapy or immunotherapy Chemotherapy: * No more than 1 prior chemotherapy regimen Endocrine therapy: * No concurrent steroids Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * No prior retinoid therapy
References
Publications (1)
- BACKGROUNDGoldberg JS, Vargas M, Rosmarin AS, Milowsky MI, Papanicoloau N, Gudas LJ, Shelton G, Feit K, Petrylak D, Nanus DM. Phase I trial of interferon alpha2b and liposome-encapsulated all-trans retinoic acid in the treatment of patients with advanced renal cell carcinoma. Cancer. 2002 Sep 15;95(6):1220-7. doi: 10.1002/cncr.10809. PMID 12216088