17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00117988
First received: July 8, 2005
Last updated: May 21, 2014
Last verified: February 2013
  Purpose

This phase II trial is studying how well 17-AAG works in treating patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or Hodgkin's lymphoma. Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.


Condition Intervention Phase
Anaplastic Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Mantle Cell Lymphoma
Drug: tanespimycin
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: A Phase II Study of 17-AAG in Patients With Relapsed/Refractory CD30+ Anaplastic Large Cell Lymphoma (ALCL), Relapsed/Refractory Mantle Cell Lymphoma (MCL), and Relapsed/Refractory Classical Hodgkin's Lymphoma (HL)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Number of Patients With Response [ Time Frame: Baseline to time to best response; Every 6 weeks ] [ Designated as safety issue: No ]
    Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses.


Enrollment: 22
Study Start Date: February 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response. After completion of study treatment, patients are followed every 3 months until disease progression.
Drug: tanespimycin
Other Name: 17-AAG

Detailed Description:

PRIMARY OBJECTIVE:

I. Determine the complete and partial response rates and time to treatment failure in patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or classical Hodgkin's lymphoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).

SECONDARY OBJECTIVES:

I. Determine the safety of this drug in these patients. II. Determine the biologic effect of this drug on selected molecular targets in primary lymphoma cells from these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type (anaplastic large cell lymphoma vs mantle cell lymphoma vs Hodgkin's lymphoma).

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response.

After completion of study treatment, patients are followed every 3 months until disease progression.

  Eligibility

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

Inclusion Criteria:

  • Negative pregnancy test
  • Fertile patients must use effective contraception prior to and during study treatment
  • Must have normal organ and marrow function
  • Not a candidate for stem cell transplantation
  • ECOG 0-2 OR Karnofsky 60-100%
  • Bilirubin normal
  • Creatinine normal
  • Histologically or cytologically confirmed relapsed or refractory mantle cell lymphoma, anaplastic large cell lymphoma (CD30-positive disease), or classical Hodgkin's lymphoma
  • Recovered from prior biologic therapy or autologous stem cell transplantation
  • Prior antibody therapy within the past 3 months allowed
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • More than 4 weeks since prior radiotherapy (12 weeks for radioimmunotherapy) and recovered
  • Recovered from prior investigational drugs
  • Recovered from prior surgery
  • More than 4 weeks since other prior anticancer therapy
  • Concurrent low-molecular weight heparin is allowed
  • Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm
  • Absolute neutrophil count >= 1,500/mm3
  • Received >= 1, but =< 3, prior treatment regimens for lymphoma (salvage therapy followed immediately by stem cell transplantation is considered 1 regimen). Single-agent monoclonal antibody therapy, cytokine therapy, or involved field radiotherapy are not considered prior treatment regimens. All prior treatments and prior antibody therapy within the past 3 months are recorded.
  • Platelet count >= 75,000/mm3
  • AST and ALT =< 1.5 times upper limit of normal
  • Understand and provide signed informed consent.

Exclusion Criteria:

  • No cardiac arrhythmia or uncontrolled dysrhythmia
  • No history of myocardial infarction within the past year
  • No New York Heart Association class III or IV heart failure
  • No other significant cardiac disease
  • No paroxysmal nocturnal dyspnea
  • No oxygen requirement
  • No AIDS
  • No history cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubcin hydrochloride, mitoxantrone, bleomycin, or carmustine)
  • No pulmonary lymphoma
  • No known CNS lymphoma
  • QTc >/= 450 msec for men
  • QTc >/= 470 msec for women
  • LVEF </= 40% by MUGA
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No symptomatic pulmonary disease requiring medication
  • No significant pulmonary disease including chronic obstructive or restrictive pulmonary disease
  • No dyspnea on or off exertion
  • No history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubcin hydrochloride, mitoxantrone, bleomycin, or carmustine)
  • Not pregnant or nursing
  • No other uncontrolled illness
  • No other active* malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No prior allogeneic stem cell transplantation
  • No history of allergic reaction to eggs
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No prior chest radiation or prior radiation that potentially included the heart in the field (e.g.,mantle).
  • No concurrent medications that prolong or may prolong QTc
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No prior cardiac symptoms >= grade 2
  • No sufficiently compromised pulmonary status (i.e., DLCO =< 80%)
  • No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation >= 3 beats in a row)
  • No prior pulmonary symptoms >= grade 2
  • HIV negative
  • No active ischemic heart disease within 12 months.
  • No congenital long QT syndrome.
  • No left bundle branch block.
  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: NCT00117988

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Anas Younes M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00117988     History of Changes
Other Study ID Numbers: NCI-2009-00101, NCI-2009-00101, CDR0000433593, 2004-0792, 6936, P30CA016672, R21CA117070
Study First Received: July 8, 2005
Results First Received: May 5, 2011
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell

ClinicalTrials.gov processed this record on August 19, 2014