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Rituximab and Combination Chemotherapy Followed By Thalidomide in Treating Patients With Previously Untreated Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Izidore Lossos, University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00450801
First received: March 20, 2007
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.


Condition Intervention Phase
Lymphoma
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Doxorubicin
Drug: Etoposide
Drug: Ifosfamide
Drug: Leucovorin
Drug: Methotrexate
Drug: Thalidomide
Drug: Vincristine
Drug: Mesna
Drug: Filgrastim (G-CSF)
Drug: Granisetron
Drug: Decadron
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (Maclo/Ivam) in Patients With Previously Untreated Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Progression-free survival at 6, 12, 18, and 24 months [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: April 2004
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MACLO IVAM Drug: Rituximab
Rituximab 375 mg/m2 IV, Days 1 of all cycles
Other Name: Rituxan
Drug: Cyclophosphamide
Cyclophosphamide 800 mg/m2 IV, Day 1, Cyclophosphamide 200 mg/m2 IV Days 2 - 5, Cycles 1 and 3. Cyclophosphamide will be given in 100 cc NS IV over 30 minutes.
Other Name: Cytoxan
Drug: Cytarabine
Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, Days 1 and 2, Cycles 2 and 4.
Other Name: AraC
Drug: Doxorubicin
Doxorubicin 45 mg/m2 IV bolus, Day 1, Cycles 1 and 3
Other Name: Adriamycin
Drug: Etoposide
Etoposide 60 mg/m2 IV daily x 5 days, Cycles 2 and 4
Other Name: VP16
Drug: Ifosfamide
Ifosfamide 1.5 grams/m2 IV QD x 5 days, Cycles 2 and 4
Other Name: Ifex
Drug: Leucovorin
Leucovorin 180 mg/m2 IV beginning 36 hours after start of methotrexate infusion and then 12 mg/m2 IV every 6 hours until methotrexate level is below 0.01 nM. Day 10, Cycles 1 and 3.
Other Name: Folinic Acid
Drug: Methotrexate
Methotrexate 1,200 mg/m2 in 250 cc D5W IV over 1 hour followed by Methotrexate 5,520 mg/m2 in 1,000 cc D5W by continuous infusion over 23 hours (240 mg/m2 every hour for 23 hours). Day 10, Cycles 1 and 3.
Other Name: amethopterin
Drug: Thalidomide
Maintenance therapy.
Other Name: Thalomid
Drug: Vincristine
Vincristine 1.5 mg/m2 IVP (maximum of 2 mg), Day 1 and 8 , Cycles 1 and 3.
Other Name: Oncovin
Drug: Mesna
Mesna 360 mg/m2 IV every 3 hours x 5 days, Cycles 2 and 4
Other Name: Mesnex
Drug: Filgrastim (G-CSF)
G-CSF 480 mcg SQ starting Day 13 (Cycles 1 and 3), Day 7 (Cycles 2 and 4)
Other Name: Neupogen
Drug: Granisetron
Granisetron 1 mg IV on Day 1, Cycle 1 and 3
Other Names:
  • Sancuso
  • Granisol
Drug: Decadron
Decadron 10 mg IV on Day 1, Cycles 1 and 3
Other Names:
  • Maxidex
  • Ozurdex
  • Baycadron

Detailed Description:

OBJECTIVES:

Primary

  • Determine the progression-free survival of patients with previously untreated mantle cell lymphoma treated rituximab in combination with methotrexate, doxorubicin, cyclophosphamide, leucovorin, vincristine, ifosfamide, etoposide, cytarabine and mesna (MACLO/IVAM) followed by thalidomide.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the response rate in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: During cycle 1, patients will receive rituximab IV, granisetron IV, decadron IV, doxorubicin IV bolus, vincristine IVP on day 1; cyclophosphamide IV on day 1-5; vincristine IVP on day 8; methotrexate IV, methotrexate by continuous infusion, then leucovorin IV until methotrexate level is below 0.01 nM on day 10. Patients will receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 13 and continuing until blood counts recover.

When absolute neutrophil count (ANC) reaches1,500/mm^3, patients will start cycle 2. Patients will receive rituximab IV on day 1; cytarabine IV on day 1 and 2; ifosfamide IV, mesna IV, etoposide IV on day 1-5; and G-CSF SC daily beginning on day 7 and continuing until ANC is greater than 1,000 cells/mm^3.

Approximately 2-3 weeks later, patients receive another course of therapy as above.After cycle 4, patients in complete remission will take oral thalidomide until progression of disease. After completion of study treatment, patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3-5 years, and then annually thereafter or at study termination.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS:

  • Histologically confirmed mantle cell lymphoma

    • All stages allowed
  • Previously untreated disease
  • Measurable or evaluable disease
  • No CNS involvement

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 6 months
  • Bilirubin < 3 mg/dL
  • SGOT and/or SGPT < 2.5 times upper limit of normal (unless due to lymphomatous involvement)
  • Creatinine < 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception during and for ≥ 4 weeks after completion of study treatment (if receiving thalidomide)
  • No other concurrent active malignancies, except for in situ carcinoma of the cervix or basal cell carcinoma of the skin

Exclusion Criteria:

Grade 3-4 cardiac failure

  • LVEF that is less than ≥ 50%
  • psychological, familial, sociological, or geographical conditions that would preclude study compliance
  • known history of HIV or AIDS
  • hepatitis or hepatitis B virus infection

PRIOR CONCURRENT THERAPY:

  • Any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450801

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Study Chair: Izidore S. Lossos, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Izidore Lossos, Professor, University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00450801     History of Changes
Other Study ID Numbers: 20030165, SCCC-2003027, WIRB-20051242
Study First Received: March 20, 2007
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Cytarabine
Doxorubicin
Etoposide
Etoposide phosphate
Granisetron
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Methotrexate
Rituximab
Thalidomide
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on November 20, 2014