Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma

NCT00025363 | Completed Phase 2

• 4 other identifiers: NCI-2012-01864ARST0121U10CA098543CDR0000068954
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alveolar Childhood Rhabdomyosarcoma; Embryonal Childhood Rhabdomyosarcoma; Embryonal-botryoid Childhood Rhabdomyosarcoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma

Outcome Measures

Primary Outcomes (2)

• Response at week 6 of investigational window therapy (unfavorable risk patients)

  At week 6

• Incidence of DLT when tirapazamine is given in combination with cyclophosphamide and doxorubicin, graded according to the NCI CTC v 2.0

  Up to 6 years

Secondary Outcomes (4)

• 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)

  Up to 6 years

• Blood metabolite SN-38 levels (unfavorable risk patients)

  Up to 6 years

• Progression-free survival

  Up to 6 years

• Survival

  Up to 6 years

Study Arms (2)

Arm I

EXPERIMENTAL

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; 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

Arm II

EXPERIMENTAL

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; 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

Interventions

vincristine sulfate DRUG

Given IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS

Arm I; Arm II

irinotecan hydrochloride DRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Arm I; Arm II

cyclophosphamide DRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

Arm I; Arm II

doxorubicin hydrochloride DRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF

Arm I; Arm II

ifosfamide DRUG

Given IV

Also known as: Cyfos, Holoxan, IFF, IFX, IPP

Arm I; Arm II

etoposide DRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213

Arm I; Arm II

tirapazamine DRUG

Given IV

Also known as: SR 4233, Tirazone, WIN 59075

Arm I; Arm II

filgrastim BIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen

Arm I; Arm II

sargramostim BIOLOGICAL

Given SC

Also known as: GM-CSF, Leukine, Prokine

Arm I; Arm II

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I; Arm II

pharmacogenomic studies OTHER

Correlative studies

Also known as: Pharmacogenomic Study

Arm I; Arm II

laboratory biomarker analysis OTHER

Correlative studies

Arm I; Arm II

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Interventions

Vincristine; Irinotecan; Cyclophosphamide; Doxorubicin; Ifosfamide; indolepropanol phosphate; Etoposide; Tirapazamine; Filgrastim; Granulocyte Colony-Stimulating Factor; sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Camptothecin; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Oxazines; Heterocyclic Compounds, 1-Ring; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Triazines; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Philip Breitfeld

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 2001
• Primary Completion: October 1, 2007
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)