Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma

Sarcoma Clinical Trial

Official title:

Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00245141
• Other study ID #: JRSG-UHA-PED03-01
• Secondary ID: CDR0000453316
• 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• 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 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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhabdomyosarcoma
• Sarcoma

Intervention

Biological:
• dactinomycin

Drug:
• cyclophosphamide

• vincristine sulfate

Radiation:
• radiation therapy

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 Prefectural Central Hospital	Izumo	Shimane
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	Tokyo Metropolitan Kiyose Children's Hospital	Kiyosei	Tokyo
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	Toyama University Hospital	Toyama
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 as measured by Kaplan-Meier method 3 years after study entry			No
Secondary	Overall survival as measured by Kaplan-Meier method 3 years after study entry			No
Secondary	Progression-free survival as measured by Kaplan-Meier method during events			No
Secondary	Complete response rate (orbit, group III only) at completion of study treatment			No
Secondary	Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry			Yes