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Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: April 25, 2007   Last Updated: November 3, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00467051
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, 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 combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors.


Condition Intervention Phase
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Ovarian Cancer
Testicular Germ Cell Tumor
Biological: filgrastim
Drug: carboplatin
Drug: ifosfamide
Drug: paclitaxel
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: November 2007
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in pediatric patients with recurrent or resistant malignant germ cell tumors treated with paclitaxel, ifosfamide, and carboplatin.

Secondary

  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood counts return to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed (at original diagnosis) extracranial germ cell tumor (GCT) containing 1 of the following malignant elements:

    • Yolk sac tumor (endodermal sinus tumor)
    • Choriocarcinoma
    • Embryonal carcinoma
  • Meets 1 of the following disease criteria:

    • Recurrent malignant disease
    • Chemotherapy-resistant disease
    • Relapsed disease
    • Disease refractory to conventional therapy
  • Measurable disease
  • Must have received a prior first-line chemotherapy regimen that included cisplatin
  • Patients with tumor marker (AFP and/or BHCG) elevation alone or bone scan findings alone are not eligible*
  • Patients with immature teratoma (any grade), germinoma, sex-cord stromal tumors, or recurrent GCT previously treated with surgery alone are not eligible NOTE: *Patients with measurable disease by imaging and elevated tumor markers do not require repeat biopsy for confirmation of recurrent disease; patients with imaging findings only (i.e., without concurrent elevation of tumor markers) require histologic confirmation of recurrence.

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 50-100% (age > 16 years) OR Lansky PS 50-100% (age ≤ 16 years) OR ECOG PS 0-2
  • Life expectancy ≥ 8 weeks
  • Absolute neutrophil count ≥ 750/mm³
  • Platelet count ≥ 75,000/mm³ (transfusion independent)
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal based on age/gender, as defined by the following:

    • ≤ 0.4 mg/dL (1 month to < 6 months of age)
    • ≤ 0.5 mg/dL (6 months to < 1 year of age)
    • ≤ 0.6 mg/dL (1 to < 2 years of age)
    • ≤ 0.8 mg/dL (2 to < 6 years of age)
    • ≤ 1.0 mg/dL (6 to < 10 years of age)
    • ≤ 1.2 mg/dL (10 to < 13 years of age)
    • ≤ 1.4 mg/dL (13 to ≥ 16 years of age) (female)
    • ≤ 1.5 mg/dL (13 to < 16 years of age) (male)
    • ≤ 1.7 mg/dL (≥ 16 years of age) (male)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • ALT < 2.5 times ULN for age
  • Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated radionuclide study
  • No dyspnea at rest
  • No exercise intolerance
  • Pulse oximetry > 94% (if there is clinical indication for determination)
  • Patients with seizure disorder are eligible provided they are on non-enzyme inducing anticonvulsants and seizures are well controlled
  • No CNS toxicity > grade 2
  • No active graft-versus-host disease
  • No allergy to Cremophor EL or castor oil
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior chemotherapy, immunotherapy, or radiotherapy
  • At least 1 week since prior growth factors (2 weeks for pegfilgrastim)
  • At least 1 week since prior biologic therapy
  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea)
  • At least 2 weeks since prior local palliative radiotherapy (i.e., small port)
  • At least 6 months since prior craniospinal radiotherapy or radiotherapy to ≥ 50% of pelvis
  • At least 6 weeks since other prior substantial bone marrow radiotherapy
  • At least 6 months since prior allogeneic stem cell transplantation
  • Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated
  • No other concurrent chemotherapy or immunomodulating agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467051

  Show 66 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Carlos Rodriguez-Galindo, MD St. Jude Children's Research Hospital
Investigator: A. Lindsay Frazier, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers: CDR0000542424, COG-AGCT0521
Study First Received: April 25, 2007
Last Updated: November 3, 2009
ClinicalTrials.gov Identifier: NCT00467051     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent childhood malignant germ cell tumor
childhood extragonadal germ cell tumor
childhood malignant ovarian germ cell tumor
childhood malignant testicular germ cell tumor
ovarian choriocarcinoma
ovarian embryonal carcinoma
recurrent ovarian germ cell tumor
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma
testicular yolk sac tumor
recurrent malignant testicular germ cell tumor
ovarian yolk sac tumor
childhood extracranial germ cell tumor

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Alkylating Agents
Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Ovarian Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Carboplatin
Antimitotic Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Ifosfamide
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Isophosphamide mustard

ClinicalTrials.gov processed this record on November 05, 2009