NCT00088868

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with an advanced solid tumor or lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 lymphoma

Timeline
Completed

Started Jun 2004

Typical duration for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

5.8 years

First QC Date

August 4, 2004

Last Update Submit

March 14, 2012

Conditions

LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificanaplastic large cell lymphomaintraocular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomaangioimmunoblastic T-cell lymphomasmall intestine lymphomaWaldenström macroglobulinemiarecurrent cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

alvespimycin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignant solid tumor OR lymphoma * Metastatic or unresectable disease * Standard curative or palliative measures are not available OR are associated with minimal survival benefit * No known brain metastases * Treated brain metastases allowed provided they have been stable ≥ 6 months without steroids or anti-seizure medications PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 * Hemoglobin \> 8 g/dL Hepatic * AST and ALT ≤ 2 times upper limit of normal * Bilirubin ≤ 1.5 times normal * PT and PTT ≤ 1.5 times normal (unless due to the presence of lupus anticoagulant or stable anticoagulation) Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No orthostatic hypotension \> grade 2 (requiring more than brief fluid replacement or other therapy OR with physiological consequences) * No New York Heart Association class III or IV heart failure * LVEF ≥ 40% by MUGA * QTc ≤ 450 msec (470 msec for women) * No congenital long QT syndrome * No myocardial infarction within the past year * No active ischemic heart disease within the past year * No history of uncontrolled dysrhythmias * No history of serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia \> 3 premature ventricular contractions in a row) * Not requiring antiarrhythmic drugs * No poorly controlled angina * No left bundle branch block Pulmonary * No uncontrolled symptomatic pulmonary disease, including any of the following: * Dyspnea off or on exertion * Paroxysmal nocturnal dyspnea * Severe chronic obstructive/restrictive pulmonary disease requiring daily chronic medications and oxygen * Must not meet the Medicare criteria for home oxygen * No sufficiently compromised pulmonary status as measured by baseline pulmonary function tests and DLCO Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation * No known HIV positivity * No hyponatremia indicated by sodium \< 130 mmol/L * No known immunodeficiency syndromes * No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (geldanamycin or 17-AAG) * No concurrent uncontrolled illness * No active or ongoing uncontrolled infection * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior biologic therapy and recovered * No concurrent prophylactic growth factors Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin, 8 weeks for UCN-01) and recovered Endocrine therapy * See Disease Characteristics * Concurrent hormonal therapy for prostate cancer allowed provided patient has metastatic disease that has progressed despite prior hormonal therapy Radiotherapy * More than 4 weeks since prior radiotherapy and recovered * No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy) Surgery * At least 4 weeks since prior major surgery Other * At least 2 weeks since prior participation in a phase 0 study * Concurrent bisphosphonates for any cancer allowed * Concurrent preventative doses of aspirin or non-steroidal anti-inflammatory drugs allowed * No concurrent drugs that may prolong QTc interval * No concurrent full anticoagulation on a regular basis * No concurrent prophylactic antiemetics * No other concurrent investigational agents or therapies * No other concurrent anticancer agents or therapies

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Large-Cell, AnaplasticIntraocular LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaMycosis FungoidesSezary SyndromeImmunoblastic LymphadenopathyWaldenstrom MacroglobulinemiaLymphoma, T-Cell, CutaneousPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellEye NeoplasmsNeoplasms by SiteLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphadenopathyNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Shivaani Kummar, MD

    NCI - Medical Oncology Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

June 1, 2004

Primary Completion

March 1, 2010

Study Completion

December 1, 2010

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(1)