Clinical trial NCT00245089: Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
Official title: Phase II Trial of VAC2.2/VA Therapy for Low-Risk B 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: 41
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. 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.

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.

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 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

Primary outcomes:
measure: Disease-free survival at 3 years after study registration
Secondary outcomes:
measure: Overall survival at 3 years after study registration
measure: Toxicity by NCI CTC at 3 years after study registration
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 University Hospital
state: Shimane
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
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: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Kyoto Prefectural University of Medicine
name: Hajime Hosoi
role: STUDY_CHAIR
affiliation: Saitama Children's Medical Center
name: Ryoji Hanada, MD
affiliation: National Hospital Orgnization Nagoya Medical Center
name: Keizo Horibe, MD, PhD
References: