Clinical trial NCT00245141: Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
Official title: Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sarcoma
Keywords: embryonal childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-10-27
Enrollment: 32
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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. 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.

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 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

Primary outcomes:
measure: Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
Secondary outcomes:
measure: Overall survival as measured by Kaplan-Meier method 3 years after study entry
measure: Progression-free survival as measured by Kaplan-Meier method during events
measure: Complete response rate (orbit, group III only) at completion of study treatment
measure: Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Anjo Kosei Hosptial
state: Aichi
city: Nagakuti
country: Japan
facility: Aichi Medical University
state: Aichi
city: Nagoya
country: Japan
facility: National Hospital Orgnization Nagoya Medical Center
state: Aichi
city: Matsuyama-shi
country: Japan
facility: Ehime Prefectural Central Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Kyushu Cancer Center
state: Fukuoka
city: Kurume City
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu Municipal Hospital
state: Gifu
city: Seta-gun
country: Japan
facility: Gunma Children's Medical Center
state: Gunma
city: Kure
country: Japan
facility: National Hospital Organization - Medical Center of Kure
state: Hiroshima
city: Sapporo
country: Japan
facility: Sapporo Medical University
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Graduate School of Medicine
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City General Hospital
state: Hyogo
city: Mito-shi
country: Japan
facility: Ibaraki Children's Hospital
state: Ibaraki
city: Tsukuba-city
country: Japan
facility: University of Tsukuba
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Kanazawa
country: Japan
facility: Kanazawa Medical University
state: Ishikawa
city: Kagoshima City
country: Japan
facility: Kagoshima City Hospital
state: Kagoshima
city: Tokyo
country: Japan
facility: National Center for Child Health and Development
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Showa University Fujigaoka Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University
state: Kanagawa
city: Miyazaki-gun
country: Japan
facility: Miyazaki Medical College University of Miyazaki
state: Miyazaki
city: Toyoshina-machi
country: Japan
facility: Nagano Children's Hospital
state: Nagano
city: Izumi
country: Japan
facility: Osaka Medical Center and Research Institute for Maternal and Child Health
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Graduate School of Medicine
state: Osaka
city: Takatsuki City
country: Japan
facility: Osaka Medical College
state: Osaka
city: Koshigaya
country: Japan
facility: Dokkyo University School of Medicine
state: Saitama
city: Tokorozawa
country: Japan
facility: National Defense Medical College
state: Saitama
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science
state: Shiga
city: Izumo
country: Japan
facility: Shimane Prefectural Central Hospital
state: Shimane
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Kiyosei
country: Japan
facility: Tokyo Metropolitan Kiyose Children's Hospital
state: Tokyo
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gifu
country: Japan
facility: Gifu University Graduate School of Medicine
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Osaka
country: Japan
facility: Osaka City University
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Saitama
country: Japan
facility: Saitama Children's Medical Center
city: Sapporo
country: Japan
facility: Hokkaido Medical Center for Child Health and Rehabilitation
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
city: Tokyo
country: Japan
facility: Toho University School of Medicine
city: Tokyo
country: Japan
facility: Keio University School of Medicine
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Kyoto Prefectural University of Medicine
name: Hajime Hosoi
role: STUDY_CHAIR
affiliation: National Center for Child Health and Development
name: Masa-aki Kumagai, MD
References: