DISCLAIMER: This site is for informational purposes only. While we make every effort to keep it up to date, there is no guarantee that information is complete, accurate, comprehensive, or the same for all KP regions. The information on this site should not be interpreted or used as a substitute for professional medical care. Please consult your care provider for any personal health questions or before participating in clinical trials.

Enrollment complete

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms Tumor

NCT No.: NCT00379340

Study Type: INTERVENTIONAL

Phase: Phase III

Region: California - Northern

Acronym: 

Official Title

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms Tumor

Purpose

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms tumor. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Detailed Description

This is a multicenter study. Regimen DD4A (weeks 1-6): Patients receive dactinomycin IV over 1-5 minutes once in week 1, vincristine IV once in weeks 1-6, and doxorubicin hydrochloride IV over 15 minutes once in week 4 in the absence of disease progression or unacceptable toxicity. Patients with both pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy once daily beginning in week 1 and continuing for 5-14 days. After completion of DD4A chemotherapy (week 6), patients undergo evaluation. Patients with stage IV disease and pulmonary metastases only with no loss of heterozygosity (LOH) who are rapid complete responders (RCR) (i.e., pulmonary metastases disappear) proceed to regimen DD4A (weeks 7-25). All other patients (i.e., patients with stage III or IV disease and LOH of both 1p and 16q, stage IV disease with pulmonary metastases only who are slow incomplete responders [SIR] [i.e., pulmonary metastases do not disappear], or stage IV disease with nonpulmonary metastases or with nonpulmonary metastases in combination with pulmonary metastases) proceed to regimen M (weeks 7-31). Patients with initially unresectable or incompletely resected tumors are reevaluated at week 6, and if resectable, undergo surgery and then proceed to either regimen DD4A or regimen M as described above. Regimen DD4A (weeks 7-25): Patients receive dactinomycin IV over 1-5 minutes once in weeks 7, 13, 19, and 25, vincristine IV once in weeks 7-10, 13, 16, 19, 22, and 25, and doxorubicin hydrochloride IV over 15 minutes once in weeks 10, 16, and 22 in the absence of disease progression or unacceptable toxicity. Regimen M (weeks 7-31): Patients receive cyclophosphamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 7, 10, 19, and 25; vincristine IV once in weeks 8, 9, 11, 12, 13, 16, 22, 28, and 31; and dactinomycin IV and doxorubicin hydrochloride IV over 15 minutes once in weeks 13, 16, 22, 28, and 31 in the absence of disease progression or unacceptable toxicity. Patients with pulmonary metastases only who are SIR also undergo whole lung radiotherapy once daily beginning in week 7 and continuing for 5-14 days. After completion of study treatment, patients are followed periodically for 10 years.

Sex

Male & Female

Age Limit

0 - 29 years

Eligibility Criteria

Inclusion Criteria

Patients must begin therapy within 14 days after surgery or biopsy (day 0), unless medically contraindicated,

Patients who previously enrolled in clinical trial COG-AREN03B2,

Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients less than or equal to 16 years of age),

AST or ALT < 2.5 times ULN,

Shortening fraction greater than or equal to 27% by echocardiogram OR ejection fraction greater than or equal to 50% by radionuclide angiogram;

Negative pregnancy test;

Exclusion Criteria

Bilirubin > 1.5 times upper limit of normal (ULN),

Pregnant or nursing,

Prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532 OR treatment for emergent issues, as medically indicated,

Concurrent aprepitant,

Keywords and/or Specific Medical Conditions

  • Alkylating Agents
  • Antibiotics, Antineoplastic
  • Antineoplastic Agents
  • Antineoplastic Agents, Alkylating
  • Antirheumatic Agents
  • AREN0533
  • Cactinomycin
  • Cyclophosphamide
  • Dactinomycin
  • Doxorubicin
  • Etoposide
  • Etoposide phosphate
  • Genetic Diseases, Inborn
  • Immunologic Factors
  • Immunosuppressive Agents
  • Kidney Diseases
  • Kidney Neoplasms
  • Liposomal doxorubicin
  • Molecular Mechanisms of Pharmacological Action
  • Myeloablative Agonists
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neoplasms, Complex and Mixed
  • Neoplastic Syndromes, Hereditary
  • Oncology (Adult)
  • Physiological Effects of Drugs
  • Urogenital Neoplasms
  • Urologic Diseases
  • Urologic Neoplasms
  • Vincristine
  • Wilms Tumor
  • Oncology (Pediatrics)

Sponsors

  • Children's Oncology Group
  • National Cancer Institute/NIH/DHHS

KP Clinical Facility

Clinical Area

  • Oncology (Adult)
  • Oncology (Pediatrics)

Principal Investigator

Aarati V Rao , MD 

Contact Information

 - CTP Collaborate Team
- CTPCollaborate@kp.org
- Roseville Medical Center

Find a study