Velcade Plus ICE for Patients With Relapsed Classical Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00439361
First received: February 22, 2007
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

Primary Objectives:

  1. To determine the toxicity profile of multiple doses of bortezomib when given with ICE in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
  2. To determine the maximum tolerated dose (MTD) of bortezomib when given in combination with ICE chemotherapy in patients with relapsed and refractory classical Hodgkin lymphoma (HL).

Secondary Objectives:

- To determine the overall response rate and complete response rate in patients with relapsed and refractory classical Hodgkin lymphoma (HL).


Condition Intervention Phase
Hodgkin Lymphoma
Lymphoma
Drug: Bortezomib
Drug: Carboplatin
Drug: Etoposide
Drug: Ifosfamide
Drug: Mesna
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase-I Study of Bortezomib (VELCADE) Plus ICE (Ifosfamide, Carboplatin, Etoposide) for Patients With Relapsed Classical Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerable Dose (MTD) of Bortezomib when given in combination with ICE chemotherapy in participants with relapsed and refractory classical Hodgkin lymphoma (HL) [ Time Frame: Two-week cycle ] [ Designated as safety issue: Yes ]
    MTD dose escalation stops either at the highest indicated dose of bortezomib (1.5 mg/m2), or when a Dose limiting toxicity (DLT) has been observed in at least one third of the patients at any dose level.


Enrollment: 14
Study Start Date: February 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bortezomib + ICE

Bortezomib + ICE (Ifosfamide, Carboplatin, Etoposide):

Bortezomib 1.0 mg/m^2 intravenous (IV) over 5 Seconds on Days 1 and 4; + ICE (Ifosfamide 5 Gm/m^2 IV continuous infusion on Day 1, Carboplatin 5 AUC IV over 1 Hour Day 1, Etoposide 100 mg/m^2 IV over 2 Hours Days 1-3) + Mesna 5 mg/m^2 IV continuous infusion Day 1; 2 Gm/m^2 IV continuous infusion over 12 Hours.

Drug: Bortezomib
1.0 mg/m^2 by Vein Over 5 Seconds on Days 1 and 4
Other Names:
  • Velcade
  • LDP-341
  • MLN341
  • PS-341
Drug: Carboplatin
5 AUC by Vein Over 1 Hour On Day 1
Other Name: Paraplatin®
Drug: Etoposide
100 mg/m^2 By Vein Over 2 Hours On Days 1-3
Other Name: VePesid®
Drug: Ifosfamide
5 Gm/m^2 By Vein Continuous Infusion Over 24 Hours On Day 1
Drug: Mesna
5 mg/m^2 IV continuous Infusion over 24 Hours On Day 1; 2 Gm/m^2 IV continuous infusion over 12 hours starting after completion of Ifosfamide + Mesna 24 hour continuous infusion
Other Name: Mesnex

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed relapsed or refractory classical Hodgkin lymphoma (nodular sclerosis, mixed cellularity, or lymphocyte-rich classical HL).
  • Patients must have failed front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
  • Bidimensionally measurable disease with at least 1 lesion >/= 2.0 cm in a single dimension
  • Acceptable hematologic status: Hemoglobin >/= 8.0 g/dL; Absolute neutrophil count >/= 1500 cells/mm^3; Platelet count >/= 100,000 cells/mm^3
  • Pre-study World Health Organization (WHO) performance status of 0, 1, or 2
  • Age greater than or equal to 16 years
  • Voluntary signed IRB approved consent informed 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.
  • Patients of reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment. 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. Female patients must not be pregnant or lactating.

Exclusion Criteria:

  • Lymphocyte predominant histology
  • More than one prior chemotherapy regimen.
  • Prior stem cell transplant
  • Abnormal liver function:Bilirubin > 2.0 mg/dL (26 µmol/L); Alkaline phosphatase > 2 * upper limits of normal (ULN); AST (SGOT) > 2 * ULN
  • Serum creatinine > 1.5 mg/dL (177 µmol/L) within 14 days before enrollment
  • Presence of CNS involvement with Hodgkin lymphoma
  • Presence of HIV infection or AIDS
  • Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Patient has hypersensitivity to boron or mannitol.
  • Prior bortezomib therapy.
  • Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years
  • Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions which would compromise protocol objectives in the opinion of the investigator and/or the sponsor.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Patient has received other investigational drugs with 14 days before enrollment
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  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: NCT00439361

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: Michelle A. Fanale, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00439361     History of Changes
Other Study ID Numbers: 2006-0527
Study First Received: February 22, 2007
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Hodgkin Lymphoma
HL
Relapsed Classical Hodgkin Lymphoma
Refractory
Lymphoma
Nodular sclerosis
Mixed cellularity
Lymphocyte-rich classical HL
Bortezomib
Velcade
LDP-341
MLN341
PS-341
Carboplatin
Paraplatin
Etoposide
VePesid®
Ifosfamide
Mesna
Mesnex
ICE

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bortezomib
Carboplatin
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Mesna
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014