Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025363
First received: October 11, 2001
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells
| Condition | Intervention | Phase |
|---|---|---|
|
Alveolar Childhood Rhabdomyosarcoma Embryonal Childhood Rhabdomyosarcoma Embryonal-botryoid Childhood Rhabdomyosarcoma Previously Treated Childhood Rhabdomyosarcoma Recurrent Childhood Rhabdomyosarcoma |
Drug: vincristine sulfate Drug: irinotecan hydrochloride Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: etoposide Drug: tirapazamine Biological: filgrastim Biological: sargramostim Other: pharmacological study Other: pharmacogenomic studies Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Disease in Rhabdomyosarcoma and Related Tumors |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Cyclophosphamide
Vincristine sulfate
Ifosfamide
Sulfate ion
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Irinotecan
Irinotecan hydrochloride
Etoposide phosphate
Filgrastim
Sargramostim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response at week 6 of investigational window therapy (unfavorable risk patients) [ Time Frame: At week 6 ] [ Designated as safety issue: No ]
- Incidence of DLT when tirapazamine is given in combination with cyclophosphamide and doxorubicin, graded according to the NCI CTC v 2.0 [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of toxicities associated with the two administration schedules of irinotecan in combination with vincristine, graded according to the NCI CTC v 2.0 (unfavorable risk patients) [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]
- Blood metabolite SN-38 levels (unfavorable risk patients) [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
- Survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
| Enrollment: | 150 |
| Study Start Date: | November 2001 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: vincristine sulfate
Given IV
Other Names:
Drug: irinotecan hydrochloride
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: ifosfamide
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: tirapazamine
Given IV
Other Names:
Biological: filgrastim
Given SC
Other Names:
Biological: sargramostim
Given SC
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: pharmacogenomic studies
Correlative studies
Other Name: Pharmacogenomic Study
Other: laboratory biomarker analysis
Correlative studies
|
|
Experimental: Arm II
Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: vincristine sulfate
Given IV
Other Names:
Drug: irinotecan hydrochloride
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: ifosfamide
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: tirapazamine
Given IV
Other Names:
Biological: filgrastim
Given SC
Other Names:
Biological: sargramostim
Given SC
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: pharmacogenomic studies
Correlative studies
Other Name: Pharmacogenomic Study
Other: laboratory biomarker analysis
Correlative studies
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Histologically confirmed rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma
- First relapse or first occurrence of disease progression
Unfavorable-risk patients eligible for study window therapy with irinotecan and vincristine meeting the following criteria:
Unfavorable risk defined by any of the following:
- Embryonal histology with stage I or group I at initial diagnosis with distant recurrence or with local or regional recurrence after prior cyclophosphamide
- Embryonal histology with initial stage II, III, or IV or group II, III, or IV with any relapse pattern
- Alveolar histology with any stage or group at initial diagnosis
- At least unidimensionally measurable disease
- No prior irinotecan
- Bone marrow must not be only site of relapse
Unfavorable-risk patients ineligible for study window therapy with irinotecan meeting the following criteria:
- Either no measurable disease OR patient received prior irinotecan
- Bone marrow as only site of relapse allowed
Favorable-risk patients meeting the following criteria:
- Initial botryoid histology (any stage, any group, or any pattern of relapse)
- Embryonal histology if either stage I or group I (with either local or regional recurrence)
- No prior cyclophosphamide
- No CNS metastases
- Performance status - ECOG 0-2
- Performance status - Zubrod 0-2
- At least 2 months
- Absolute neutrophil count at least 750/mm^3
- Platelet count at least 75,000/mm^3 (transfusion independent)
- Hemoglobin at least 10.0 g/dL (red blood cell transfusion allowed)
- Bilirubin no greater than 1.5 times normal
- SGPT less than 2.5 times normal
- Creatinine no greater than 1.5 times normal
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- Shortening fraction at least 27% by echocardiogram
- Ejection fraction at least 50% by MUGA
- No prior ischemic heart disease
- Seizure disorder allowed if well controlled by anticonvulsants
- No CNS toxicity greater than grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior myeloablative therapy with stem cell transplantation
- At least 1 week since prior antineoplastic biologic agent
- At least 1 week since prior growth factor(s)
- Recovered from prior immunotherapy
- No concurrent immunomodulating agents
- See Disease Characteristics
- See Biologic therapy
- No more than 1 prior chemotherapy regimen
- No prior doxorubicin or daunorubicin
- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No other concurrent anticancer chemotherapy
- Concurrent corticosteroid therapy allowed
- At least 2 weeks since prior small-port radiotherapy.
- At least 6 months since prior radiotherapy to 50% or more of pelvis
- At least 6 weeks since other prior substantial radiotherapy to bone marrow
- Recovered from prior radiotherapy
- Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated
- No concurrent intensity-modulated radiotherapy
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025363 History of Changes |
| Other Study ID Numbers: | NCI-2012-01864, ARST0121, U10CA098543, CDR0000068954 |
| Study First Received: | October 11, 2001 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhabdomyosarcoma Rhabdomyosarcoma, Embryonal Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Cyclophosphamide Ifosfamide Isophosphamide mustard Irinotecan Tirapazamine Doxorubicin Etoposide |
Vincristine Camptothecin Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 23, 2013