Phase 2
N=291
Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
Childhood Renal Cell Carcinoma · Clear Cell Renal Cell Carcinoma · Clear Cell Sarcoma of the Kidney · Papillary Renal Cell Carcinoma · Rhabdoid Tumor of the Kidney
Bottom Line
View on ClinicalTrials.gov: NCT00335556 ↗Enrolled (actual)
291
Serious AEs
9.7%
Results posted
Jun 2017
Primary outcome: Primary: Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT) — 76.1; 25.0; 87.5 Percentage of 4-year OS — p=.0199
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Doxorubicin Hydrochloride (Drug); Irinotecan Hydrochloride (Drug); Conventional Surgery (Procedure); Cyclophosphamide (Drug); Etoposide (Drug); Carboplatin (Drug); Dactinomycin (Biological); Vincristine Sulfate (Drug); Radiation Therapy (Radiation); Laboratory Biomarker Analysis (Other)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT) |
76.1; 25.0; 87.5 | .0199 sig |
| PRIMARY Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors |
38.9 | .3478 |
| PRIMARY Response Rate |
71 | — |
| PRIMARY Event Free Survival Probability |
100.0 | .0570 |
| PRIMARY Toxicity Rate |
4.9; 4.9; 0 | — |
| SECONDARY Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization |
23; 1 | — |
| SECONDARY Frequency of TP53 Mutations |
— | — |
Summary
This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed disease of 1 of the following histologic types:
- Focal anaplastic Wilms' tumor
- Diffuse anaplastic Wilms' tumor
- Clear cell sarcoma of the kidney
- Malignant rhabdoid tumor (renal or extrarenal)
- Renal cell carcinoma
- Clear cell
- Papillary
- Renal medullary
- Oncocytoid
- Sarcomatoid
- Chromophobe
- Translocation
- Collecting duct
- Carcinoma associated with neuroblastoma
- Renal cell carcinoma unclassified
- Specimens/materials must be submitted for central review by Day 7
- Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy (surgery/biopsy is Day 0), unless medically contraindicated
- Karnofsky performance status (PS) must be >= 50 for patients > 16 years if age and Lansky PS must be >= 50 for patients = = 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram
- Female patients of childbearing age must have a negative pregnancy test
- Female patients who are lactating must agree to stop breast-feeding
- Sexually active patients of childbearing potential must agree to use effective contraception
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Data sourced from ClinicalTrials.gov (NCT00335556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.