Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma - Full Text View

Sponsor:	Japan Rhabdomyosarcoma Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00245089

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. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma.

Condition	Intervention	Phase
Sarcoma	Biological: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Cyclophosphamide Dactinomycin Vincristine Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival at 3 years after study registration [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival at 3 years after study registration [ Designated as safety issue: No ]
Toxicity by NCI CTC at 3 years after study registration [ Designated as safety issue: Yes ]

Estimated Enrollment:	41
Study Start Date:	May 2004
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the progression-free survival rate in patients with low-risk embryonal rhabdomyosarcoma treated with intensive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide followed by vincristine and dactinomycin.

OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 41 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

Criteria

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 II (N1)
  - Favorable site
  - Any tumor size
  - Microscopic residual disease
  - Lymph nodes clinically positive
- Stage I, clinical group III (N1)
  - Favorable site (orbit only)
  - Any tumor size
  - Gross residual disease
  - Lymph nodes clinically positive
- Stage I, clinical group III (N0, NX, N1)
  - Favorable site (except orbit)
  - Any tumor size
  - Gross residual disease
  - Lymph nodes clinically negative, involvement unknown, or positive
- Stage II, clinical group II (N0, NX)
  - Unfavorable site
  - Small tumor (≤ 5 cm in diameter)
  - Microscopic residual disease
- Stage III, clinical group I or II (N0, NX, N1)
  - Unfavorable site
  - Small tumor (≤ 5 cm in diameter) with positive nodes or large tumor (> 5 cm in diameter) with any lymph nodes status
  - Completely resected or microscopic residual disease

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
No uncontrolled infection
Must have acceptable organ function for age
No other malignancy within the past 5 years
No hypersensitivity attributed to study drugs
No Charcot-Marie-Tooth disease or chickenpox

PRIOR CONCURRENT THERAPY:

Chemotherapy

No prior anticancer chemotherapy

Endocrine therapy

Prior anticancer steroids allowed

Radiotherapy

Prior emergency radiotherapy allowed within the past 2 weeks

Other

No concurrent pentostatin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245089

Show 48 Study Locations

Sponsors and Collaborators

Japan Rhabdomyosarcoma Study Group

Investigators

Study Chair:	Hajime Hosoi	Kyoto Prefectural University of Medicine
Investigator:	Ryoji Hanada, MD	Saitama Children's Medical Center
Investigator:	Keizo Horibe, MD, PhD	National Hospital Orgnization Nagoya Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000450162, JRSG-UHA-PED03-02
Study First Received:	October 25, 2005
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00245089 History of Changes
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:

Neoplasms, Muscle Tissue
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Rhabdomyosarcoma, Embryonal
Neoplasms, Connective and Soft Tissue
Anti-Bacterial Agents
Dactinomycin
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

Rhabdomyosarcoma
Neoplasms by Histologic Type
Myosarcoma
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Protein Synthesis Inhibitors
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Sarcoma
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 25, 2009