Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of two treatment regimens for patients in developing countries with diffuse non-Hodgkin's lymphoma and acute lymphoblastic leukemia.


Study summary:

OBJECTIVES: - Provide a standard protocol for specific therapy that is relatively easy to administer and relatively inexpensive but conforms to modern treatment principles, and determine whether such therapy can be administered safely and effectively in patients with acute lymphoblastic lymphoma or diffuse non-Hodgkin's lymphoma who live in developing countries. - Determine the rates of relapse and survival in patients treated with these protocols, and relate this data to disease subtype and clinical presentation in order to obtain a database on which to build future stratagems. OUTLINE: This is a multicenter study. Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma with any degree of bone marrow involvement are assigned to Protocol MCP-841. Patients with mediastinal or localized lymphoblastic lymphoma (a single nodal or extranodal site) without bone marrow involvement, or other types of diffuse non-Hodgkin's lymphoma with or without bone marrow involvement are assigned to Protocol MCP-842. Protocol MCP-841: - First induction therapy: Patients receive daunorubicin (DNR) IV on days 8, 15, and 29; vincristine (VCR) IV on days 1, 8, 15, 22, and 29; asparaginase (ASP) intramuscularly (IM) every other day on days 2-20; oral prednisone (PRED) on days 1-28; and methotrexate (MTX) intrathecally (IT) on days 1, 8, 15, and 22. Second induction therapy: Patients receive oral mercaptopurine (MP) on days 1-7 and 15-21; cyclophosphamide (CTX) IV over 30 minutes on days 1 and 15; MTX IT as in first induction therapy; and cranial irradiation on days 4-14. - Alternative to second induction (if a cranial irradiation facility is unavailable): Patients receive MP and CTX as in second induction therapy; cytarabine (ARA-C) IV every 12 hours on days 1, 2, 15, 16, 29, and 30; and MTX IT on days 8 and 22. Patients with low-risk disease (WBC no greater than 10,000/mm3, age 3 to 6 years, no prominent lymphadenopathy (less than 3 cm in diameter in each nodal region), normal CSF, no mediastinal mass, no enlargement of liver or spleen, and no cranial nerve palsies) proceed directly to maintenance therapy. All other patients are considered high risk, and they repeat first induction therapy and then proceed to consolidation therapy. - Consolidation therapy: Patients receive MP and CTX as in second induction therapy, VCR IV on days 1 and 15, and ARA-C subcutaneously (SC) every 12 hours on days 1-3 and 15-17. - Maintenance therapy: Patients receive VCR IV on day 1; DNR IV on day 1; oral PRED on days 1-7; ASP IM on days 1, 3, 5, and 7; and oral MTX once weekly and oral MP daily on days 15-35, 43-63, and 71-91. Maintenance therapy continues for a total of 6 courses. Protocol MCP-842: - Patients undergo surgical resection of intra-abdominal masses, if feasible. Patients with low-risk disease (completely resected tumor or a single extra-abdominal site of involvement (other than the mediastinum), but without lymphoblastic lymphoma) are assigned to treatment group 2. All other patients, including those with lymphoblastic lymphoma without bone marrow involvement, are considered high risk and they are assigned to treatment group 1. - Group 1 (high risk): Patients receive one course of regimen A comprising CTX IV over 15 minutes on days 1-4; VCR IV on days 1, 8, and 15; doxorubicin (DOX) IV on days 1 and 2; ARA-C IV over 3 hours every 12 hours on day 1; ARA-C IT on day 4; and MTX IT on days 8 and 12. Patients then receive one course of regimen B comprising ifosfamide IV over 30 minutes on days 1-5, etoposide IV over 1 hour and MTX IV on days 1-3, VCR IV on day 8, ARA-C IT on days 1 and 4, and MTX IT as in regimen A. Patients then receive a second course of regimen A, followed by a second course of regimen B. - Group 2 (low risk): Patients receive one course of regimen A, followed by one course of regimen B, and then a second course of regimen A. DOX is withheld during both courses of regimen A. IT therapy is withheld during the second course of regimen A. Patients are followed every 2 months for 1 year (Protocol MCP-841) or at 1, 2, 3, 4, 6, and 8 months (Protocol MCP-842), every 6 months for 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Newly diagnosed acute lymphoblastic leukemia (ALL) - Lymphoblasts comprising more than 25% of nucleated cells on bone marrow aspirate - Associated with an appropriate clinical syndrome - OR - Histologically proven newly diagnosed diffuse non-Hodgkin's lymphoma (NHL) - Immunologic and/or cytochemical confirmation of diagnosis preferred PATIENT CHARACTERISTICS: Age: - ALL: - Under 25 - NHL: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No prior therapy for ALL or NHL


Study is Available At:


Original ID:

CDR0000077227


NCT ID:

NCT00018954


Secondary ID:

NCI-92-C-0030


Study Acronym:


Brief Title:

Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia and Diffuse Non-Hodgkin's Lymphoma


Official Title:

PILOT MULTINATIONAL PROTOCOLS IN ACUTE LYMPHOBLASTIC LEUKEMIA AND DIFFUSE NON-HODGKIN'S LYMPHOMA


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

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

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Ian Trevor Magrath, MD, FRCP, FRCPath
Study Chair
NCI - Pediatric Oncology Branch

Study Dates

Start Date:October 1992
Verification Date:April 2000
Last Changed Date:February 6, 2009
First Received Date:July 11, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:asparaginase
Intervention Type:Drug
Name:cyclophosphamide
Intervention Type:Drug
Name:cytarabine
Intervention Type:Drug
Name:daunorubicin hydrochloride
Intervention Type:Drug
Name:doxorubicin hydrochloride
Intervention Type:Drug
Name:etoposide
Intervention Type:Drug
Name:ifosfamide
Intervention Type:Drug
Name:mercaptopurine
Intervention Type:Drug
Name:methotrexate
Intervention Type:Drug
Name:prednisone
Intervention Type:Drug
Name:vincristine sulfate
Intervention Type:Procedure
Name:conventional surgery
Intervention Type:Radiation
Name:radiation therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Gad-el-Mawla N, Hussein MH, Abdel-Hadi S, el-Taneer O, Adde M, Magrath I. Childhood non-Hodgkin's lymphoma in Egypt: preliminary results of treatment with a new ifosfamide-containing regimen. Cancer Chemother Pharmacol. 1989;24 Suppl 1:S20-3.
PMID:2758567

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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