Clinical trial · Interventional

Combination Chemotherapy in Treating Children With Stage III or Stage IV Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia

A Pilot Study of Dose Intensification of Methotrexate and Cyclophosphamide in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Non-Hodgkins Lymphoma and B-Cell All- A Limited Institution Phase III Pilot Study

NCT00003217CI-TRIAL-00015216completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of methotrexate and cyclophosphamide in treating children who have stage III or stage IV non-Hodgkin's lymphoma or acute lymphoblastic leukemia.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
cytarabine	Drug	Cytarabine	ALIAS
dexamethasone	Drug	Dexamethasone	ALIAS
doxorubicin hydrochloride	Drug	Doxorubicin	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
methotrexate	Drug	Methotrexate	ALIAS
vincristine sulfate	Drug	Vincristine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment
description
See detailed description.
interventionNames
1. Biological: filgrastim
2. Drug: cyclophosphamide
3. Drug: cytarabine
4. Drug: dexamethasone
5. Drug: doxorubicin hydrochloride
6. Drug: methotrexate
7. Drug: vincristine sulfate

Primary outcomes (1)

measure
Event Free Survival

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 21 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS: Cytologically proven small, noncleaved cell non-Hodgkin's lymphoma, Burkitt's lymphoma, non-Burkitt's lymphoma, or B cell acute lymphoblastic leukemia (B-ALL) Stage III or IV B-ALL - must have FAB L3 morphology and have been registered on POG-9400

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV antibody positive allowed Not pregnant or lactating

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior emergency steroid therapy may be allowed Radiotherapy: Prior emergency radiotherapy may be allowed Surgery: Prior surgery allowed Other: No concurrent dexamethasone as an anti-emetic

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Mar 1, 1998
Primary completion: Oct 1, 2004
Completion: Sep 1, 2006
First posted: Sep 6, 2004
Last update posted: Jul 25, 2014
Enrollment: 20 (actual)
Lead sponsor: Children's Oncology Group NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: childhood Burkitt lymphoma, untreated childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, stage III childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma

Data updated 22 days agoSource updated Jul 25, 2014source: clinicaltrials

Locations

Locations by country (14)

Country	Sites	Recruiting
United States	12	0
Canada	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.