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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00245089
• Other study ID #: JRSG-UHA-PED03-02
• Secondary ID: CDR0000450162
• Status: Recruiting
• Phase: Phase 2
• First received: October 25, 2005
• Last updated: August 9, 2013
• Start date: May 2004

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhabdomyosarcoma
• Sarcoma

Intervention

Biological:
• dactinomycin

Drug:
• cyclophosphamide

• vincristine sulfate

Locations

Country	Name	City	State
Japan	Anjo Kosei Hosptial	Anjo	Aichi
Japan	National Kyushu Cancer Center	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Gifu University Graduate School of Medicine	Gifu
Japan	Gifu Municipal Hospital	Gifu-shi	Gifu
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	Hiroshima University Hospital	Hiroshima
Japan	Osaka Medical Center and Research Institute for Maternal and Child Health	Izumi	Osaka
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Kagoshima University	Kagoshima
Japan	Kagoshima City Hospital	Kagoshima City	Kagoshima
Japan	Kanazawa Medical University	Kanazawa	Ishikawa
Japan	Ishikawa Prefectural Central Hospital	Kanazawa-shi	Ishikawa
Japan	Kobe City General Hospital	Kobe	Hyogo
Japan	Dokkyo University School of Medicine	Koshigaya	Saitama
Japan	National Hospital Organization - Medical Center of Kure	Kure	Hiroshima
Japan	Kurume University School of Medicine	Kurume City	Fukuoka
Japan	Kyoto Prefectural University of Medicine	Kyoto
Japan	Kyoto University Hospital	Kyoto
Japan	Ehime Prefectural Central Hospital	Matsuyama-shi	Ehime
Japan	Ibaraki Children's Hospital	Mito-shi	Ibaraki
Japan	Miyazaki Medical College University of Miyazaki	Miyazaki-gun	Miyazaki
Japan	Aichi Medical University	Nagakuti	Aichi
Japan	National Hospital Orgnization Nagoya Medical Center	Nagoya	Aichi
Japan	Osaka City University	Osaka
Japan	Osaka General Medical Center	Osaka
Japan	Shiga University of Medical Science	Otsu-shi	Shiga
Japan	Saitama Children's Medical Center	Saitama
Japan	Hokkaido Medical Center for Child Health and Rehabilitation	Sapporo
Japan	Hokkaido University Graduate School of Medicine	Sapporo	Hokkaido
Japan	Sapporo Medical University	Sapporo	Hokkaido
Japan	Gunma Children's Medical Center	Seta-gun	Gunma
Japan	Osaka City General Hospital	Suita-shi	Osaka
Japan	Osaka University Graduate School of Medicine	Suita-shi	Osaka
Japan	Osaka Medical College	Takatsuki City	Osaka
Japan	National Defense Medical College	Tokorozawa	Saitama
Japan	Keio University School of Medicine	Tokyo
Japan	National Cancer Center Hospital	Tokyo
Japan	National Center for Child Health and Development	Tokyo	Kanagawa
Japan	Nihon University Itabashi Hospital	Tokyo
Japan	St. Luke's International Hospital	Tokyo
Japan	Toho University School of Medicine	Tokyo
Japan	Tokyo Medical and Dental University	Tokyo
Japan	Nagano Children's Hospital	Toyoshina-machi	Nagano
Japan	University of Tsukuba	Tsukuba-city	Ibaraki
Japan	Yamagata University Hospital	Yamagata
Japan	Yokohama City University	Yokohama	Kanagawa
Japan	Showa University Fujigaoka Hospital	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Japan Rhabdomyosarcoma Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival at 3 years after study registration			No
Secondary	Overall survival at 3 years after study registration			No
Secondary	Toxicity by NCI CTC at 3 years after study registration			Yes