Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
Recruitment status was Recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, 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 radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma |
- Disease-free survival as measured by Kaplan-Meier method 3 years after study entry [ Designated as safety issue: No ]
- Overall survival as measured by Kaplan-Meier method 3 years after study entry [ Designated as safety issue: No ]
- Progression-free survival as measured by Kaplan-Meier method during events [ Designated as safety issue: No ]
- Complete response rate (orbit, group III only) at completion of study treatment [ Designated as safety issue: No ]
- Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 32 |
| Study Start Date: | May 2004 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine, dactinomycin, and cyclophosphamide with or without radiotherapy.
OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of 24 weeks) in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of embryonal rhabdomyosarcoma
- Primary operation for pathological diagnosis within the past 42 days
The following variants are eligible:
- Botryoid
- Spindle cell
- Anaplastic
Meets 1 of the following stage criteria:
Stage I, clinical group I or II (N0), defined by all of the following criteria:
- Favorable site, including orbit, head, and neck (excluding parameningeal sites), genitourinary region (excluding bladder/prostate sites), or biliary tract
- Tumor any size
- Completely resected disease OR microscopic residual disease
- Lymph nodes clinically negative
Stage I, clinical group III (N0), defined by all of the following criteria:
- Favorable site
- Tumor any size
- Gross residual disease allowed (orbit only)
- Lymph nodes clinically negative
Stage II, clinical group I (N0, Nx), defined by all of the following criteria:
- Unfavorable site (any sites not listed as favorable sites)
- Tumor ≤ 5 cm in diameter
- Completely resected disease
- Lymph nodes clinically negative OR lymph node involvement unknown
PATIENT CHARACTERISTICS:
Performance status
- 0-3
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 7.5 g/dL
Hepatic
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
- Bile acid ≤ 2.5 times ULN
Renal
Creatinine based on age as follows:
- < 0.8 mg/dL (for patients < 5 years of age)
- < 1.2 mg/dL (for patients 5-9 years of age)
- < 1.5 mg/dL (for patients ≥ 10 years of age)
Cardiovascular
- No severe heart disease
Other
- Not pregnant or nursing
- Must have acceptable organ function for age
- No uncontrolled infection
- No other active malignancy
- No other treated malignancy within the past 5 years
- No hypersensitivity to study drugs
- No Charcot-Marie-Tooth disease
- No chickenpox
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior anticancer chemotherapy
Endocrine therapy
- Prior anticancer steroids allowed
Radiotherapy
- No prior radiotherapy
Other
- No concurrent pentostatin
Contacts and Locations
Show 51 Study Locations| Study Chair: | Hajime Hosoi | Kyoto Prefectural University of Medicine |
| Investigator: | Masa-aki Kumagai, MD | National Center for Child Health and Development |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00245141 History of Changes |
| Other Study ID Numbers: | CDR0000453316, JRSG-UHA-PED03-01 |
| Study First Received: | October 25, 2005 |
| Last Updated: | July 7, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
embryonal childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma previously untreated childhood rhabdomyosarcoma |
Additional relevant MeSH terms:
|
Rhabdomyosarcoma Rhabdomyosarcoma, Embryonal Sarcoma Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Dactinomycin Cyclophosphamide Vincristine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Anti-Bacterial Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on May 22, 2013