Clinical trial · Interventional
Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
A Phase I/II Study Of Interleukin-12-Primed Activated T Cells In Combination With 5FU, GM-CSF And Interferon Alfa-2b In Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma
- 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: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of biological therapy combined with chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Response as measured by RECIST guidelines and Kaplan-Meier method at 5 years
- measure
- Survival as measured by the Kaplan-Meier method at 5 years
- measure
- Safety as measured by NCI common toxicity table at study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic renal cell carcinoma or colorectal carcinoma, meeting 1 of the following criteria: * Obtained no benefit from prior standard or salvage therapy * Ineligible for standard therapy because of concurrent illness * Declined standard therapy * At least 1 site of measurable disease that can be measured in at least 1 dimension * At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan * No untreated or unstable, treated brain metastasis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 4,000/mm\^3 * Granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * No coagulation disorders Hepatic: * Bilirubin no greater than 2.5 mg/dL\* * ALT/AST less than 3 times upper limit of normal\* * PT no greater than 1.5 times control (unless therapeutically anticoagulated) * PTT less than 1.5 times control (unless therapeutically anticoagulated) NOTE: \*Patients whose cancer has led to values that do not fall within the above ranges may be eligible at the discretion of the investigators Renal: * Creatinine no greater than 2.0 mg/dL\* NOTE: \*Patients whose cancer has led to values that do not fall within the above range may be eligible at the discretion of the investigators Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No thrombophlebitis Pulmonary: * FEV\_1 and FVC at least 65% predicted * No uncontrolled pulmonary embolism Other: * No other malignancy within the past 5 years except resected basal cell skin cancer or carcinoma in situ of the cervix * No prior allergic reactions attributed to compounds of similar chemical or biologic composition to interleukin-12-primed activated T cells or other study agents * No active autoimmune disease * No uncontrolled thyroid abnormalities * No ongoing or active infection * No other uncontrolled concurrent illness * No psychiatric illness or social situations that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 2 years after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 4 weeks since prior immunotherapy Chemotherapy: * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * At least 4 weeks since prior steroid therapy or steroid-containing compounds * At least 2 weeks since prior topical or inhaled steroids Radiotherapy: * More than 4 weeks since prior radiotherapy and recovered Surgery: * More than 4 weeks since prior major surgery Other: * No other concurrent investigational agents * No other concurrent commercial anticancer agents * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (0)
Data not yet available