Velcade Plus ICE for Patients With Relapsed Classical Hodgkin Lymphoma

NCT00439361 | Completed Phase 1

• 1 other identifier: 2006-0527
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 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. 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).

Conditions

Hodgkin Lymphoma; Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerable Dose (MTD) of Bortezomib when given in combination with ICE chemotherapy in participants with relapsed and refractory classical Hodgkin lymphoma (HL)

  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.

  Two-week cycle

Study Arms (1)

Bortezomib + ICE

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide; Drug: Mesna

Interventions

Bortezomib DRUG

1.0 mg/m\^2 by Vein Over 5 Seconds on Days 1 and 4

Also known as: Velcade, LDP-341, MLN341, PS-341

Bortezomib + ICE

Carboplatin DRUG

5 AUC by Vein Over 1 Hour On Day 1

Also known as: Paraplatin®

Bortezomib + ICE

Etoposide DRUG

100 mg/m\^2 By Vein Over 2 Hours On Days 1-3

Also known as: VePesid®

Bortezomib + ICE

Ifosfamide DRUG

5 Gm/m\^2 By Vein Continuous Infusion Over 24 Hours On Day 1

Bortezomib + ICE

Mesna DRUG

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

Also known as: Mesnex

Bortezomib + ICE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma

Interventions

Bortezomib; Carboplatin; Etoposide; Ifosfamide; Mesna

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Officials

• Michelle A. Fanale, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 23, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

US (1)