Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma - Full Text View

Sponsor:	Japan Rhabdomyosarcoma Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00245141

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial of Short VAC1.2 Therapy for Low-Risk A 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 as measured by Kaplan-Meier method 3 years after study entry [ Designated as safety issue: No ]

Secondary Outcome Measures:

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)

Detailed Description:

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

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245141

Show 51 Study Locations

Sponsors and Collaborators

Japan Rhabdomyosarcoma Study Group

Investigators

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:

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

No publications provided

Study ID Numbers:	CDR0000453316, JRSG-UHA-PED03-01
Study First Received:	October 25, 2005
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00245141 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 February 08, 2010