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Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin

Phase 2
21 Years
Open (Enrolling)
Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor

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Trial Information

Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin



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


- 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

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.

Inclusion Criteria


- 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.


- 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


- 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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response as measured by RECIST criteria

Safety Issue:


Principal Investigator

Carlos Rodriguez-Galindo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Federal Government

Study ID:




Start Date:

November 2007

Completion Date:

Related Keywords:

  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • 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
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal



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