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

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ClinicalTrials.gov Identifier: NCT00117988
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : May 30, 2011
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE July 8, 2005
First Posted Date  ICMJE July 11, 2005
Results First Submitted Date  ICMJE May 5, 2011
Results First Posted Date  ICMJE May 30, 2011
Last Update Posted Date May 30, 2014
Study Start Date  ICMJE February 2005
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
Number of Patients With Response [ Time Frame: Baseline to time to best response; Every 6 weeks ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00117988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma
Official Title  ICMJE 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)
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anaplastic Large Cell Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Mantle Cell Lymphoma
Intervention  ICMJE Drug: tanespimycin
Other Name: 17-AAG
Study Arms  ICMJE 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.
Intervention: Drug: tanespimycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2014)
22
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00117988
Other Study ID Numbers  ICMJE NCI-2009-00101
NCI-2009-00101 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000433593
2004-0792 ( Other Identifier: M D Anderson Cancer Center )
6936 ( Other Identifier: CTEP )
P30CA016672 ( U.S. NIH Grant/Contract )
R21CA117070 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anas Younes M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP