Bortezomib and Reduced Intensity Allogenic Stem Cell Transplantation for Lymphoid Malignancies
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00439556
First received: February 22, 2007
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
The goal of this clinical research study is to find the highest tolerable dose of Velcade (bortezomib) that can be given with BEAM (carmustine, etoposide, cytarabine and melphalan) and rituximab in patients with lymphoma who receive a stem cell transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Carmustine Drug: Cytarabine Drug: Etoposide Drug: Melphalan Drug: Rituximab Drug: Bortezomib Other: Allogeneic Stem Cell Infusion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bortezomib (Velcade) and Reduced-Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoid Malignancies |
Resource links provided by NLM:
Drug Information available for:
Cytarabine
Melphalan
Carmustine
Melphalan hydrochloride
Etoposide
Etoposide phosphate
Rituximab
Bortezomib
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum tolerated dose (MTD) [ Time Frame: 90 days after the start of treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 52 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bortezomib + Reduced Intensity Allo SCT
Bortezomib + BEAM (Carmustine, Etoposide, Cytarabine and Melphalan) + Rituximab Allo SCT = Allogeneic Stem Cell Transplantation |
Drug: Carmustine
300 mg/m^2 IV on Day -6
Other Names:
Drug: Cytarabine
100 mg/m^2 IV twice a day x 4 Days (Days -5 through -2)
Other Names:
Drug: Etoposide
100 mg/m^2 IV twice a day x 4 Days (Days -5 through -2)
Other Name: VePesid
Drug: Melphalan
100 mg/m^2 IV on Day -1
Drug: Rituximab
375 mg/m^2 IV on Day -13; 1000 mg/m^2 on Days -6, 1, & 8.
Other Name: Rituxan
Drug: Bortezomib
1.3 mg/m^2 IV on Days -13, -6, -1 and +2.
Other Names:
Other: Allogeneic Stem Cell Infusion
Allogeneic Stem Cell Infusion administered on Day 0.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Up to 70 years of age.
- Any histological subtype of CD20+ lymphoid malignancies or T-cell lymphoid malignancies.
- Patients with CD20+ lymphoid malignancies in relapse after failing >/= 1 prior regimen of conventional treatment and not eligible for non-myeloablative transplant. Patients with T-Cell lymphoid malignancies can either be in relapse or newly diagnosed with high risk features (such as high IPI of >/= 2).
- Patients with prior non-myeloablative transplant are eligible if not from the same donor.
- A fully-matched or one-antigen mismatched sibling or unrelated donor.
- Left ventricular EF >/= 40% with no uncontrolled arrythmias or symptomatic heart disease..
- FEV1, FVC and DLCO >/= 40%.
- Serum creatinine < 1.8 mg/dL. Serum bilirubin < 3X upper limit of normal,
- SGPT < 3X upper limit of normal.
- Voluntary signed, written IRB-approved informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
Exclusion Criteria:
- Past history of anaphylaxis following exposure to rituximab or VELCADE®, boron or mannitol
- History of grade 3 or 4 NCI toxicity with prior VELCADE® therapy
- Patient with active CNS disease.
- Pregnant (Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.
- Patients with other malignancies diagnosed within 2 years prior to Study Day -13 (except skin squamous or basal cell carcinoma).
- Active uncontrolled bacterial, viral or fungal infections.
- Major surgical procedure or significant traumatic injury within 4 weeks prior to Day -13.
- Serious, non-healing wound, ulcer, or bone fracture.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 3 months prior to Day -13.
- History of Stroke within 6 months.
- Myocardial infarction within the past 6 months prior to Study Day 1, or has New York Heart Association (NYHA) Class III or IV heart failure or arrythmia, unstable angina, uncontrolled congestive heart failure or arrythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.Prior to study entry, any ECG abnormality at screening must be documented by investigator as not medically relevant.
- Uncontrolled hypertension(>/=140/90) .
- Uncontrolled chronic diarrhea.
- A prior allogeneic transplant from the same donor.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Patient has received other investigational drugs within 3 weeks before enrollment.
- Active peripheral neuropathy greater or equal to grade 2.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439556
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Issa F. Khouri, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00439556 History of Changes |
| Other Study ID Numbers: | 2006-0066 |
| Study First Received: | February 22, 2007 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Lymphoma Bortezomib Velcade LDP-341 MLN341 PS-341 Carmustine Cytarabine Etoposide Melphalan |
Rituximab BEAM BCNU BiCNU® ARA-C Cytosar DepoCyt® Cytosine arabinosine hydrochloride VePesid® Rituxan |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Carmustine Melphalan Etoposide phosphate Rituximab Bortezomib Cytarabine Etoposide Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Myeloablative Agonists Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013