Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
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| ClinicalTrials.gov Identifier: NCT00467051 |
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Recruitment Status :
Completed
First Posted : April 27, 2007
Results First Posted : March 20, 2015
Last Update Posted : August 29, 2018
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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Brief Summary:
This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Childhood Extracranial Germ Cell Tumor Childhood Extragonadal Malignant Germ Cell Tumor Childhood Malignant Ovarian Germ Cell Tumor Childhood Malignant Testicular Germ Cell Tumor Ovarian Choriocarcinoma Ovarian Embryonal Carcinoma Ovarian Yolk Sac Tumor Recurrent Childhood Malignant Germ Cell Tumor Recurrent Malignant Testicular Germ Cell Tumor Recurrent Ovarian Germ Cell Tumor Testicular Choriocarcinoma Testicular Embryonal Carcinoma Testicular Mixed Choriocarcinoma and Embryonal Carcinoma Testicular Mixed Choriocarcinoma and Yolk Sac Tumor Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor Testicular Yolk Sac Tumor | Drug: Carboplatin Biological: Filgrastim Drug: Ifosfamide Other: Laboratory Biomarker Analysis Drug: Paclitaxel | Phase 2 |
PRIMARY OBJECTIVES:
I. Determine the response rate in pediatric patients with recurrent or resistant malignant germ cell tumors (GCT) treated with paclitaxel, ifosfamide, and carboplatin.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the tumor bank that will aid in the identification of the biological characteristics of recurrent GCT.
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 count returns 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin |
| Actual Study Start Date : | November 5, 2007 |
| Actual Primary Completion Date : | March 1, 2012 |
| Actual Study Completion Date : | June 30, 2018 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ifosfamide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (chemotherapy, biological therapy)
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 count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
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Drug: Carboplatin
Given IV
Other Names:
Biological: Filgrastim Given IV or subcutaneously
Other Names:
Drug: Ifosfamide Given IV
Other Names:
Other: Laboratory Biomarker Analysis Optional correlative studies Drug: Paclitaxel Given IV
Other Names:
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Primary Outcome Measures :
- Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days) ]Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.
Secondary Outcome Measures :
- The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity. [ Time Frame: Two cycles of chemotherapy; expected to be 42 days of treatment. ]
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| Ages Eligible for Study: | up to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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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
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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
- 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)
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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
- No other concurrent chemotherapy or immunomodulating agents
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467051
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Carlos Rodriguez-Galindo | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00467051 History of Changes |
| Other Study ID Numbers: |
AGCT0521 NCI-2009-00374 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-AGCT0521 CDR0000542424 AGCT0521 ( Other Identifier: Childrens Oncology Group ) AGCT0521 ( Other Identifier: CTEP ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 27, 2007 Key Record Dates |
| Results First Posted: | March 20, 2015 |
| Last Update Posted: | August 29, 2018 |
| Last Verified: | October 2017 |
Additional relevant MeSH terms:
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Carcinoma Neoplasms Neoplasms, Germ Cell and Embryonal Germinoma Ovarian Neoplasms Testicular Neoplasms Carcinoma, Embryonal Endodermal Sinus Tumor Choriocarcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Genital Neoplasms, Male Genital Diseases, Male Testicular Diseases Mesonephroma Trophoblastic Neoplasms Adenocarcinoma Pregnancy Complications, Neoplastic Pregnancy Complications Paclitaxel Isophosphamide mustard |