Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma

Sponsor

Japan Rhabdomyosarcoma Study Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00245089

Collaborator

(none)

Enrollment

Locations

0.9

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Sarcoma	Biological: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

41 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma

Study Start Date :

May 1, 2004

Anticipated Primary Completion Date :

Apr 1, 2011

Outcome Measures

Primary Outcome Measures

Disease-free survival at 3 years after study registration []

Secondary Outcome Measures

Overall survival at 3 years after study registration []
Toxicity by NCI CTC at 3 years after study registration []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Locations

	Site	City	State	Country	Postal Code
1	Anjo Kosei Hosptial	Anjo	Aichi	Japan	446-8602
2	Aichi Medical University	Nagakuti	Aichi	Japan	480-1103
3	National Hospital Orgnization Nagoya Medical Center	Nagoya	Aichi	Japan	460-0001
4	Ehime Prefectural Central Hospital	Matsuyama-shi	Ehime	Japan	790-0024
5	National Kyushu Cancer Center	Fukuoka-shi	Fukuoka	Japan	811-1395
6	Kurume University School of Medicine	Kurume City	Fukuoka	Japan	830-0011
7	Gifu Municipal Hospital	Gifu-shi	Gifu	Japan	500-8513
8	Gunma Children's Medical Center	Seta-gun	Gunma	Japan	377-8577
9	National Hospital Organization - Medical Center of Kure	Kure	Hiroshima	Japan	737-0023
10	Sapporo Medical University	Sapporo	Hokkaido	Japan	060-8556
11	Hokkaido University Graduate School of Medicine	Sapporo	Hokkaido	Japan	060-8638
12	Kobe City General Hospital	Kobe	Hyogo	Japan	650
13	Ibaraki Children's Hospital	Mito-shi	Ibaraki	Japan	311-4145
14	University of Tsukuba	Tsukuba-city	Ibaraki	Japan	305-8575
15	Ishikawa Prefectural Central Hospital	Kanazawa-shi	Ishikawa	Japan	920-02
16	Kanazawa Medical University	Kanazawa	Ishikawa	Japan	920-8641
17	Kagoshima City Hospital	Kagoshima City	Kagoshima	Japan	892-8580
18	National Center for Child Health and Development	Tokyo	Kanagawa	Japan	157-8535
19	Showa University Fujigaoka Hospital	Yokohama-shi	Kanagawa	Japan	227-8502
20	Yokohama City University	Yokohama	Kanagawa	Japan	236-0004
21	Miyazaki Medical College University of Miyazaki	Miyazaki-gun	Miyazaki	Japan	889-1692
22	Nagano Children's Hospital	Toyoshina-machi	Nagano	Japan	399-8288
23	Osaka Medical Center and Research Institute for Maternal and Child Health	Izumi	Osaka	Japan	594-1101
24	Osaka City General Hospital	Suita-shi	Osaka	Japan	565-0871
25	Osaka University Graduate School of Medicine	Suita-shi	Osaka	Japan	565-0871
26	Osaka Medical College	Takatsuki City	Osaka	Japan	569-8686
27	Dokkyo University School of Medicine	Koshigaya	Saitama	Japan	343-8555
28	National Defense Medical College	Tokorozawa	Saitama	Japan	359-8513
29	Shiga University of Medical Science	Otsu-shi	Shiga	Japan	520-21
30	Shimane University Hospital	Izumo	Shimane	Japan	693-8501
31	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka	Japan	430-8558
32	Fukushima Medical University Hospital	Fukushima		Japan	960-1295
33	Gifu University Graduate School of Medicine	Gifu		Japan	500-8705
34	Hiroshima University Hospital	Hiroshima		Japan	734-8551
35	Kagoshima University	Kagoshima		Japan	890-8520
36	Kyoto Prefectural University of Medicine	Kyoto		Japan	602-8566
37	Kyoto University Hospital	Kyoto		Japan	606-8507
38	Osaka City University	Osaka		Japan	545-8586
39	Osaka General Medical Center	Osaka		Japan	558-0056
40	Saitama Children's Medical Center	Saitama		Japan	339-8551
41	Hokkaido Medical Center for Child Health and Rehabilitation	Sapporo		Japan	006-0041
42	National Cancer Center Hospital	Tokyo		Japan	104-0045
43	St. Luke's International Hospital	Tokyo		Japan	104
44	Tokyo Medical and Dental University	Tokyo		Japan	113-8510
45	Toho University School of Medicine	Tokyo		Japan	143-8541
46	Keio University School of Medicine	Tokyo		Japan	160-8582
47	Nihon University Itabashi Hospital	Tokyo		Japan	173
48	Yamagata University Hospital	Yamagata		Japan	990-9585