Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Rare Diseases

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Burkitt Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Anti-Infective Agents

Antirheumatic Agents

Antiemetics

Gastrointestinal Agents

Micronutrients

Dermatologic Agents

Reproductive Control Agents

Bone Density Conservation Agents

Hematinics

Vitamins

Etoposide

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cytarabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Dexamethasone

Leucovorin

Levoleucovorin

Methotrexate

Prednisone

Vincristine

Calcium

Ifosfamide

Dexamethasone acetate

Etoposide phosphate

Calcium, Dietary

Isophosphamide mustard

Cobalt

Mesna

Hydrocortisone-17-butyrate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antiviral Agents

Antidotes

Protective Agents

Trace Elements

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

Patients receive combination therapy as described in the study description. All patients must complete at least the first 3 courses of chemotherapy. Courses 2 and 3 each repeat 3 times in the absence of disease progression or unacceptable toxicity. On days 134-139, patients who have had prior bone marrow involvement receive cranial radiation therapy. Patients who achieve less than a complete response and who have an HLA-matched sibling should undergo allogeneic bone marrow transplant on protocol CLB-9113. Patients are followed monthly for 6 months, every 2 months for 18 months, every 6 months for 2 years, and thereafter for survival.

cyclophosphamide

cytarabine

dexamethasone

doxorubicin hydrochloride

etoposide

ifosfamide

leucovorin calcium

mesna

methotrexate

prednisone

therapeutic hydrocortisone

vincristine sulfate

low-LET cobalt-60 gamma ray therapy

low-LET photon therapy

Edward Lee, MD

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 and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.

OBJECTIVES: I. Determine the response rate and disease free survival of HIV seronegative patients with diffuse small noncleaved cell lymphoma or L3 acute lymphocytic leukemia when treated with high intensity, brief duration combination chemotherapy: alternating courses of ifosfamide/cytarabine/etoposide and cyclophosphamide/doxorubicin, each with methotrexate/vincristine/dexamethasone. II. Determine the toxicity of these regimens in HIV negative patients.

OUTLINE: Patients are stratified by participating institution and disease type (diffuse small noncleaved cell lymphoma vs L3 ALL). Patients receive cyclophosphamide IV over 5-10 minutes on days 1 through 5 and oral prednisone on days 1 through 7, followed by alternating courses of: 2) ifosfamide IV over 1 hour on days 8 through 12, methotrexate IV over 24 hours on day 8; leucovorin calcium IV over 36 hours after initiation of methotrexate, then IV (or orally as tolerated, after the first 24 hours) every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M; vincristine IV on day 8; cytarabine IV over 48 hours and etoposide IV over 60 minutes on days 11 and 12; and oral dexamethasone on days 8 through 12, plus triple intrathecal therapy (TIT) with methotrexate, cytarabine, and hydrocortisone on days 8 and 12, and 3) cyclophosphamide IV over 5-10 minutes on days 29 through 33; methotrexate IV over 24 hours and vincristine IV on day 29; leucovorin calcium IV over 36 hours after initiation of methotrexate, then IV (or orally as tolerated, after the first 24 hours) every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M; doxorubicin IV on days 32 and 33; and oral dexamethasone on days 29 through 33, plus TIT on day 29, with doses as above. Patients with CNS disease at diagnosis continue TIT once weekly until the CSF clears, then weekly for 4 more weeks. TIT must be completed prior to initiation of radiotherapy. All patients must complete at least the first 3 courses of chemotherapy. Courses 2 and 3 each repeat 3 times in the absence of disease progression or unacceptable toxicity. On days 134-139, patients who have had prior bone marrow involvement receive cranial radiation therapy. Patients who achieve less than a complete response and who have an HLA-matched sibling should undergo allogeneic bone marrow transplant on protocol CLB-9113. Patients are followed monthly for 6 months, every 2 months for 18 months, every 6 months for 2 years, and thereafter for survival.

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

HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR DIFFUSE SMALL NONCLEAVED CELL LYMPHOMA AND THE L-3 SUBTYPE OF ALL: A PILOT STUDY OF A MULTIDRUG REGIMEN

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Lymphoma, Large B-Cell, Diffuse

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Lymphoma, Non-Hodgkin

Diffuse Large B-Cell Lymphoma

Lymphoma, Large-cell, Immunoblastic

Analgesics

Neuroprotective Agents

Mitoxantrone

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

mitoxantrone hydrochloride

prednisolone

Eric Michael Bessell, MD, PhD, FRCP, FRCR

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: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of cyclophosphamide, vincristine, and prednisolone, with either mitoxantrone or doxorubicin in treating patients with intermediate- or high-grade non-Hodgkin's lymphoma.

OBJECTIVES: I. Assess the treatment-related neurologic and hematologic toxicities of patients aged 65 years and over with intermediate- or high-grade non-Hodgkin's lymphoma randomized to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) vs. MCOP (mitoxantrone, cyclophosphamide, vincristine, prednisolone). II. Compare the survival rate in these patients.

OUTLINE: Randomized study. The following acronyms are used: CHOP CTX/DOX/VCR/PRDL CTX Cyclophosphamide, NSC-26271 DHAD Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 MCOP DHAD/CTX/VCR/PRDL PRDL Prednisolone, NSC-9900 VCR Vincristine, NSC-67574 Arm I: 4-Drug Combination Chemotherapy. CHOP. Arm II: 4-Drug Combination Chemotherapy. MCOP.

PROJECTED ACCRUAL: A total of 200 patients will be entered over approximately 5 years.

Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma

A RANDOMIZED PROSPECTIVE TRIAL OF CHOP VERSUS MCOP IN ELDERLY PATIENTS WITH INTERMEDIATE AND HIGH GRADE NON-HODGKIN'S LYMPHOMA (AGED 65 YEARS AND OVER)

Cancer Research Campaign Clinical Trials Centre

Heart and Blood Diseases

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Indolent B Cell Lymphoma

Antibodies

Antibodies, Monoclonal

Rituximab

Immunoglobulins

Interferons

Interferon-alpha

Antineoplastic Agents, Immunological

recombinant interferon alfa

rituximab

Robert O. Dillman, MD, FACP

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus interferon alfa or rituximab in treating patients who have high risk stage III or stage IV lymphoma.

OBJECTIVES: I. Determine the toxicity of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with either interferon alfa or rituximab in patients with stage III or IV high risk indolent or intermediate B-cell lymphoma. II. Determine the objective tumor response rate and duration of response for these regimens in these patients. III. Determine the failure free survival and overall survival for these patients on these regimens. IV. Compare the response rate and survival rate of these patients on these regimens to similar patients treated in published studies. V. Compare the toxicities of these regimens in these patients. VI. Determine the quality of life of these patients on these regimens.

OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment arms: Arm I: Patients receive rituximab IV on day 0, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Arm II: Patients receive interferon alfa subcutaneously on days 22-26, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Treatment repeat every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to chemotherapy for each course. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for up to 10 years.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per treatment arm) will be accrued for this study.

Combination Chemotherapy Plus Interferon Alfa or Rituximab in Treating Patients With Stage III or Stage IV Lymphoma

Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma

Cancer Biotherapy Research Group

Hoag Memorial Hospital Presbyterian

Robert O. Dillman, MD

Symptoms and General Pathology

Multiple Myeloma

Neoplasms, Plasma Cell

Plasmacytoma

Recurrence

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, B-Cell, Marginal Zone

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Chronic Lymphocytic Leukemia

Marginal Zone Lymphoma

Anti-Dyskinesia Agents

Cyclosporine

Cyclosporins

Tacrolimus

Bleomycin

Acyclovir

Trimethoprim, Sulfamethoxazole Drug Combination

Trimethoprim

Sulfamethoxazole

Interferon alpha-2

Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week.

bleomycin sulfate

dose varies during initial immunosuppression. During chemotherapy, 60 mg/m\^2.

Simple excision, for those patients who have resectable disease after initial immunosuppression.

conventional surgery

For treatment of localized disease that remains after initial immunosuppression.

radiation therapy

Lode J. Swinnen, MD

Leo I. Gordon, MD

RATIONALE: Reducing the amount of drugs used to prevent transplant rejection may help a person's body kill tumor cells. Giving biological therapy, such as interferon alfa, which may interfere with the growth of cancer cells, or combination chemotherapy, which uses different ways to stop tumor cells from dividing so they stop growing or die, may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of reducing immunosuppression, and giving interferon alfa and combination chemotherapy, in treating patients who have malignant tumors that develop after organ transplant.

OBJECTIVES: I. Evaluate the complete remission rate and survival of patients with lymphoproliferation following organ transplantation treated with a defined sequential approach: modification of immunosuppression, with surgery or limited radiotherapy for an isolated site of disease; interferon alfa; and chemotherapy (ProMACE-CytaBOM; cyclophosphamide, doxorubicin, etoposide, prednisone, cytarabine, bleomycin, vincristine, methotrexate).

OUTLINE: All patients receive modification of immunocompetence, unless rejection is present at outset. These patients proceed directly to interferon treatment. Group 1 (see Disease Characteristics): Patients receive reduced doses of their current immunosuppressive therapy for 10 days. Group 2: Patients receive reduced doses of some of their current immunosuppressive therapy and discontinue some of the other therapy for 14 days. Immunosuppressive therapy then resumes on day 15. Immunosuppressive therapy continues throughout other therapy, unless otherwise noted. Some patients may then undergo surgery or radiotherapy. Interferon therapy: Patients receive interferon alfa (IFNA) subcutaneously or intramuscularly on days 1-28 for a maximum of 3 courses. Patients then receive maintenance therapy with IFNA 3 days a week for 4 weeks for up to 6 courses. Chemotherapy (ProMACE-CytaBOM): Immunosuppressive therapy is stopped on days 1-20. Patients receive cyclophosphamide IV, doxorubicin IV, and etoposide IV over 60 minutes on day 1, oral prednisone on days 1-14, and cytarabine IV, bleomycin IV, vincristine IV, and methotrexate IV on day 8. Treatment is repeated every 21 days for up to 6 courses. Patients with positive CSF cytology receive intrathecal methotrexate or cytarabine on days 1, 3, 5, 7, and 14. Some patients may continue this therapy on day 21 , then every 3 weeks for 5 doses, or may receive cranial irradiation. Patients are followed monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 4-5 years.

SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant

Phase II Trial of Sequential Modification of Immunosuppression, Interferon Alpha, and Promace-Cytabom For Treatment of Post-Cardiac Transplant Lymphoproliferation.

Eastern Cooperative Oncology Group

SWOG Cancer Research Network

Childhood Acute Lymphoblastic Leukemia

Lenograstim

filgrastim

peripheral blood stem cell transplantation

Ann Traynor, MD

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy and chemotherapy plus peripheral stem cell transplantation in treating patients who have high-grade lymphoma or acute lymphoblastic leukemia.

OBJECTIVES: I. Determine the toxicity of an intensive induction regimen comprised of etoposide with cyclophosphamide and total body irradiation (TBI) in patients with high grade lymphoma or acute lymphoblastic leukemia (ALL). II. Determine the maximum tolerated dose of etoposide when combined with cyclophosphamide and TBI in these patients. III. Determine the response rate in patients treated with this induction regimen. IV. Determine the potential for long term survival in patients with relapsed lymphoblastic lymphoma and chemotherapy responsiveness treated with this induction regimen. V. Determine the efficacy of this induction regimen followed by autologous peripheral blood stem cell transplantation (APBSCT) in patients with ALL in any complete remission. VI. Determine the efficacy of this induction regimen followed by APBSCT in patients will ALL after relapse and remission reinduction.

OUTLINE: This is a dose escalation study of etoposide. Patients undergo total body irradiation twice daily on days -8 to -5. Patients receive etoposide IV over 30 hours beginning on day -5 and cyclophosphamide IV over 1 hour on day -3 (beginning 6 hours after completion of etoposide infusion) and day -2. Peripheral blood stem cells are reinfused on day 0. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts have recovered for 2 days. Cohorts of 5 patients receive escalating doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 5 patients experience dose limiting toxicity. Patients are followed every month for 1 year and then every 6 months for 2.5 years.

PROJECTED ACCRUAL: A minimum of 5 patients will be accrued for this study.

Radiation Therapy and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With High-Grade Lymphoma or Acute Lymphoblastic Leukemia

Dose Escalation of VP-16 With Cyclophosphamide and Total Body Irradiation as Preparative Regimen for Autologous Transplantation for High-Grade Lymphoma and Acute Lymphoblastic Leukemia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia	NCT00002494	Leukemia Lymphoma	cyclophosphamid... cytarabine dexamethasone doxorubicin hyd... etoposide ifosfamide leucovorin calc... mesna methotrexate prednisone therapeutic hyd... vincristine sul... low-LET cobalt-... low-LET photon ...	15 Years -	Alliance for Clinical Trials in Oncology
Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma	NCT00002576	Lymphoma	cyclophosphamid... doxorubicin hyd... mitoxantrone hy... prednisolone vincristine sul...	65 Years -	National Cancer Institute (NCI)
Combination Chemotherapy Plus Interferon Alfa or Rituximab in Treating Patients With Stage III or Stage IV Lymphoma	NCT00004039	Lymphoma	recombinant int... rituximab cyclophosphamid... doxorubicin hyd... prednisone vincristine sul...	-	Hoag Memorial Hospital Presbyterian
Combination Chemotherapy Plus Interferon Alfa or Rituximab in Treating Patients With Stage III or Stage IV Lymphoma	NCT00004039	Lymphoma	recombinant int... rituximab cyclophosphamid... doxorubicin hyd... prednisone vincristine sul...	-	Hoag Memorial Hospital Presbyterian
Combination Chemotherapy Plus Interferon Alfa or Rituximab in Treating Patients With Stage III or Stage IV Lymphoma	NCT00004039	Lymphoma	recombinant int... rituximab cyclophosphamid... doxorubicin hyd... prednisone vincristine sul...	-	Hoag Memorial Hospital Presbyterian
SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant	NCT00002657	Lymphoma Multiple Myelom...	bleomycin sulfa... recombinant int... cyclophosphamid... cytarabine doxorubicin hyd... etoposide methotrexate prednisone vincristine sul... conventional su... radiation thera...	15 Years -	SWOG Cancer Research Network
Radiation Therapy and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With High-Grade Lymphoma or Acute Lymphoblastic Leukemia	NCT00004898	Leukemia Lymphoma	filgrastim cyclophosphamid... etoposide peripheral bloo... radiation thera...	- 65 Years	Northwestern University
SWOG-8819 Collecting, Analyzing, and Storing Tissue Samples From Patients With Non-Hodgkin's Lymphoma	NCT00900484	Lymphoma	biologic sample... immunohistochem... laboratory biom...	16 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for stage ii adult burkitt lymphoma