Sacramento, California 95817

  • Lymphoma

Purpose:

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 II trial to study the effectiveness of combination chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.


Study summary:

OBJECTIVES: - Determine if increasing the methotrexate dose in combination with standard treatment is feasible in patients with advanced small noncleaved cell non-Hodgkin's lymphoma or B-cell acute lymphocytic leukemia. - Assess the toxicity of this intensified therapy in these patients. - Assess the feasibility of treating these patients that have CNS disease at diagnosis with this intensified therapy plus etoposide and ifosfamide. - Assess toxicities and late effects of this intensive therapy on the central nervous system, cardiac function, and fertility in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to stage and disease (stage III non-Hodgkin's lymphoma (NHL) vs stage IV NHL with no CNS involvement vs stage IV NHL with CNS involvement vs B-cell acute lymphocytic leukemia (B-ALL) with no CNS involvement vs B-ALL with CNS involvement). Patients receive methotrexate and cytarabine intrathecally on days 1, 4, 11, and 36 (on day 40 for patients with stage IV NHL or B-ALL only) in combination with alternating courses of: A) cyclophosphamide IV every 12 hours for a total of six doses on days 1-3, doxorubicin IV over 30 minutes on day 4, vincristine IV on days 4 and 11, dexamethasone IV or orally twice daily on days 1-5, and filgrastim (G-CSF) subcutaneously (SQ) or IV over 30 minutes beginning on day 5 and continuing until blood counts recover and B) methotrexate IV over 24 hours on day 18, methotrexate intrathecally on day 18, dexamethasone IV or orally twice daily on days 18-22, leucovorin calcium IV or orally every 6 hours for a total of 6 doses on days 20-21, cytarabine IV over 48 hours on days 20-21, and G-CSF SQ or IV over 30 minutes beginning on day 22 and continuing until blood counts recover. Patients with stage III NHL receive at total of 5 courses of treatment (A-B-A-B-A) and patients with stage IV NHL or B-ALL with no CNS involvement receive a total of 6 courses of treatment (A-B-A-B-A-B). Patients with CNS involvement receive a third course of treatment: C) etoposide IV over 1 hour on days 36-40, ifosfamide IV over 1 hour on days 36-40, oral dexamethasone twice daily on days 36-40, and G-CSF SQ or IV over 30 minutes beginning on day 41 and continuing until blood counts recover. Patients with CNS involvement receive a total of 7 courses of treatment (A-B-C-A-B-A-B). Patients are followed every 6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: A total of 27-80 patients will be accrued for this study over 24 months.


Criteria:

DISEASE CHARACTERISTICS: - One of the following diagnoses: - Histologically confirmed small noncleaved cell non-Hodgkin's lymphoma - Stage III or IV - Burkitt's or non-Burkitt's by the Working Formulation OR - Burkitt's or Burkitt's-like by the REAL classification - Histologically confirmed B-cell acute lymphocytic leukemia - At least 25% blasts in bone marrow - FAB L3 morphology - FAB L1 morphology allowed if blasts show B-cell markers (CD19, 20, 22) and surface immunoglobulin positivity - Must be registered on POG-9900 in past 8 days PATIENT CHARACTERISTICS: Age: - Under 22 at time of diagnosis Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - Negative pregnancy test - HIV positive allowed PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No concurrent use of dexamethasone as antiemetic Radiotherapy: - Not specified Surgery: - Prior surgery allowed Other: - No prior therapy except surgery


Study is Available At:


Original ID:

9917


NCT ID:

NCT00005977


Secondary ID:

COG-9917


Study Acronym:


Brief Title:

Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

N/A


Maximum Age:

22 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

83


Enrollment Type:

Actual


Overall Contact Information

Official Name:Hazem H. Mahmoud, MD
Study Chair
Carol G. Simon Cancer Center at Morristown Memorial Hospital

Study Dates

Start Date:September 2000
Completion Date:September 2006
Completion Type:Actual
Primary Completion Date:March 2004
Primary Completion Type:Actual
Verification Date:August 2013
Last Changed Date:August 19, 2013
First Received Date:July 5, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure:Event-free survival
Time Frame:1 year
Safety Issues:True
Description:Assess the effect of high dose methotrexate in combination with standard treatment per the POG 9317 protocol on 1-year event-free survival (EFS), monitor and assess toxicity, and estimate the hospitalization costs for the treatment of toxicity related sid

Study Interventions

Intervention Type:Biological
Name:filgrastim
Description:Given IV
Arm Name:STAGE III NHL (Trt 1)
Other Name:GRANULOCYTE COLONY-STIMULATING FACTOR
Intervention Type:Drug
Name:cyclophosphamide
Description:Given IV
Arm Name:STAGE III NHL (Trt 1)
Other Name:CTX
Intervention Type:Drug
Name:cytarabine
Description:Given IV
Arm Name:STAGE III NHL (Trt 1)
Other Name:cytosine arabinoside
Intervention Type:Drug
Name:dexamethasone
Description:Given IV
Arm Name:STAGE III NHL (Trt 1)
Other Name:DECADRON
Intervention Type:Drug
Name:doxorubicin hydrochloride
Description:Given IV
Arm Name:STAGE III NHL (Trt 1)
Other Name:Adriamycin
Intervention Type:Drug
Name:etoposide
Description:Given IV
Arm Name:STAGE IV, +CNS (Trt 3)
Other Name:VP-16
Intervention Type:Drug
Name:ifosfamide
Description:Given IV
Arm Name:STAGE IV, +CNS (Trt 3)
Other Name:IFX
Intervention Type:Drug
Name:leucovorin calcium
Description:Given IV
Arm Name:STAGE III NHL (Trt 1)
Other Name:LCV
Intervention Type:Drug
Name:methotrexate
Description:Given IV
Arm Name:STAGE III NHL (Trt 1)
Other Name:MTX
Intervention Type:Drug
Name:vincristine sulfate
Description:Given IV
Arm Name:STAGE III NHL (Trt 1)
Other Name:VCR

Study Arms

Study Arm Type:Experimental
Arm Name:STAGE III NHL (Trt 1)
Description:A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. Treatment ABABA
Study Arm Type:Experimental
Arm Name:STAGE IV NHL, -CNS (Trt 2)
Description:A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. Treatment ABABAB
Study Arm Type:Experimental
Arm Name:STAGE IV, +CNS (Trt 3)
Description:A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy. Treatment ABCABAB
Study Arm Type:Experimental
Arm Name:B-ALL, -CNS (Trt 2)
Description:A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. Treatment ABABAB
Study Arm Type:Experimental
Arm Name:B-ALL, +CNS (Trt 3)
Description:A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy. Treatment ABCABAB

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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