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Chemotherapy in Treating Patients With Retinoblastoma

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00002675
First received: November 1, 1999
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with retinoblastoma.


Condition Intervention Phase
Retinoblastoma
Biological: filgrastim
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: mesna
Drug: vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A TRIAL OF ADJUVANT CHEMOTHERAPY IN PATIENTS WITH INTRAOCULAR RETINOBLASTOMA

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 50
Study Start Date: May 1995
Study Completion Date: January 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Estimate the response rate to adjuvant carboplatin (CBDCA) alone in children with intraocular retinoblastoma. II. Assess the overall survival, disease-free survival, and time to treatment failure in these patients. III. Attempt to maintain a 90% disease-free survival rate with this treatment. IV. Estimate the percentage of disease-free survivors who do not require the use of radiotherapy after adjuvant CBDCA. V. Assess the toxicity of this treatment. VI. Estimate the percentage of functional eyes salvaged using this radiation-sparing protocol and compare these results, in a nonrandomized manner, with historical treatment results in this population.

OUTLINE: Patients are stratified according to vitreous disease (yes vs no). Patients receive carboplatin IV over 1 hour on day 0. Treatment repeats every 2-3 weeks for 2 courses. Patients achieving complete response (CR) proceed to local control measures consisting of cryotherapy, laser photocoagulation, etc. (except brachytherapy). Patients not achieving CR continue with carboplatin until local control measures feasible. Patients with vitreous disease achieving CR receive 2 additional courses and then receive local control measures. Patients with vitreous disease not achieving CR receive intensive chemotherapy. Patients receive intensive chemotherapy consisting of vincristine IV on days 0, 7, and 14, cisplatin IV over 6 hours on day 0, etoposide IV on days 1 and 2, followed by cyclophosphamide IV over 60 minutes on days 1 and 2. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 3 and until blood counts recover. Treatment repeats every 2-4 weeks for 2 courses beyond CR. Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-6 years.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Intraocular retinoblastoma Ophthalmologic exam under anesthesia within 3 weeks prior to registration No pathologic confirmation required No evidence of extraocular disease, i.e.: Negative head MRI or CT (contrast not required) Negative CSF cytology Negative bone marrow aspiration and biopsy

PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dl SGOT or SGPT less than 5 times upper limit of normal Renal: Creatinine normal for age OR Creatinine clearance greater than 50 ml/min

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002675

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Ira Dunkel, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002675     History of Changes
Other Study ID Numbers: 95-040, CDR0000064317, NCI-V95-0710
Study First Received: November 1, 1999
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
intraocular retinoblastoma

Additional relevant MeSH terms:
Retinoblastoma
Eye Diseases
Eye Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Retinal Diseases
Retinal Neoplasms
Cyclophosphamide
Vincristine
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014