Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

Conditions

• Childhood Renal Cell Carcinoma
• Clear Cell Renal Cell Carcinoma
• Clear Cell Sarcoma of the Kidney
• Papillary Renal Cell Carcinoma
• Rhabdoid Tumor of the Kidney
• Stage I Renal Cell Cancer
• Stage I Renal Wilms Tumor
• Stage II Renal Cell Cancer
• Stage II Renal Wilms Tumor
• Stage III Renal Cell Cancer
• Stage III Renal Wilms Tumor
• Stage IV Renal Cell Cancer
• Stage IV Renal Wilms Tumor

Eligibility Criteria

Sex

ALL

Age

N/A - 29 Years

Healthy Volunteers

Not accepted

Interventions

• Doxorubicin Hydrochloride — DRUG
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Conventional Surgery — PROCEDURE
  Patients undergo resection
• Cyclophosphamide — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Carboplatin — DRUG
  Given IV
• Dactinomycin — BIOLOGICAL
  Given IV
• Vincristine Sulfate — DRUG
  Given IV
• Radiation Therapy — RADIATION
  Undergo radiotherapy
• Laboratory Biomarker Analysis — OTHER
  Correlative studies

Study Details

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.

Key Dates

Start date

Jun 30, 2006

Status verified

Apr 2016

Primary completion

Dec 31, 2015

Study Design

Enrollment

291 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Surgery
  Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician's choice.
• Experimental: Treatment (UH-1)
  Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, and carboplatin. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable clear cell sarcoma of the kidney (CCSK) receive no further study therapy.
• Experimental: Treatment (window/UH-1)
  Patients receive vincristine IV on days 1 and 8 and irinotecan hydrochloride IV over 30 minutes on days 1-5 and 8-12 (course 1). Patients with progressive disease (PD) are treated with regimen UH-1. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive another course of irinotecan hydrochloride/vincristine window therapy beginning on day 22. After the second course, patients with SD or PD are treated with regimen UH-1 and patients with PR or CR are treated with regimen UH-2.
• Experimental: Treatment (UH-2)
  Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, carboplatin, and irinotecan hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 7. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 7.
• Experimental: Treatment (regimen I)
  Patients receive vincristine, doxorubicin hydrochloride, cyclophosphamide, and etoposide. Patients whose primary tumors were initially resected (except those with stage I CCSK) undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.
• Experimental: Treatment (regimen DD-4A)
  Patients receive dactinomycin, vincristine, and doxorubicin hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.

Primary Outcome Measure

Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT) [ Time Frame: 4 years ]

Locations (161)

Find similar trials in Birmingham, AL

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