NCT00019708

Brief Summary

Phase I trial to study the effectiveness of geldanamycin analogue in treating patients who have advanced solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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, 1999

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

10.8 years

First QC Date

July 11, 2001

Last Update Submit

December 13, 2013

Conditions

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueNodal Marginal Zone B-cell LymphomaNon-Hodgkin LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Marginal Zone LymphomaRecurrent Small Lymphocytic LymphomaSplenic Marginal Zone 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 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 LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of tanespimycin

    DLT are defined as any greater than or equal to grade 3 non-hematologic toxicity (except for alopecia of any grade, grade 3 nausea or vomiting during less than maximal antiemetic therapy, and grade 3 fever in the absence of neutropenia and infection), any grade 4 hematologic toxicity (except for anemia of any grade), or the inability to resume treatment by day 42 (longer than two week delay) because of drug related toxicity.

    28 days

Secondary Outcomes (2)

  • Biomolecular effects of tanespimycin in normal tissues such as peripheral blood and bone marrow mononuclear cells

    Up to day 5

  • Pharmacokinetics of tanespimycin

    Pre-infusion, 20 minutes, 40, 50, 60 (end of infusion), 70, 80, 95 and 110 minutes, and 2.5, 3, 4, 5, 6.5, 8, 10, 14 and 24 hours

Study Arms (1)

Treatment (tanespimycin)

EXPERIMENTAL

Patients will receive infusions of tanespimycin analogue twice a week in weeks 1 and 3.

Drug: tanespimycin

Interventions

tanespimycinDRUG

Given IV

Also known as: 17-AAG
Treatment (tanespimycin)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Criteria: * Platelet count at least 100,000/mm\^3 * No leukemia * No active CNS involvement with tumor * ECOG 0-2 * Life expectancy: at least 3 months * Absolute neutrophil count at least 2,000/mm\^3 * No New York Heart Association class III or IV heart failure * No history of myocardial infarction within the past year * Bilirubin =\< upper limit of normal (ULN) * AST no greater than 2 times ULN (no greater than 98 U/L) * No uncontrolled dysrhythmias * No poorly controlled angina * No serious ventricular arrhythmia (i.e., ventricular tachycardia (VT) or ventricular fibrillation (VF) \>= 3 beats in a row) * QTc interval =\< 450 msec for men or =\< 470 msec for women * LVEF \>= 40% by MUGA * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other serious medical condition that would preclude study participation * No serious hypersensitivity to egg products * No concurrent anticancer immunotherapy * At least 4 weeks since prior chemotherapy and recovered * No other concurrent anticancer chemotherapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone \[CHOP\] or mechlorethamine, vincristine, procarbazine, and prednisone \[MOPP\]) * No concurrent anticancer hormonal therapy * Concurrent glucocorticoids as antiemetics for nonmalignant disease allowed * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy * No concurrent major surgery * No concurrent anticancer glucocorticoids * Creatinine =\< ULN or Creatinine clearance at least 60 mL/min * No concurrent medications that cause QTc prolongation * Histologically confirmed advanced solid tumor for which no curative therapy exists * Non-Hodgkin's lymphoma allowed * No concurrent drugs that interfere with hepatic CYP3A4 metabolism (e.g., grapefruit juice, ketoconazole, fluconazole, itraconazole, cyclosporine, erythromycin, clarithromycin, cimetidine, terfenadine, astemizole, indinavir, or nelfinavir mesylate)

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

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal ZoneLymphoma, Non-HodgkinBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Mantle-Cell

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean Grem

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

June 1, 1999

Primary Completion

April 1, 2010

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

US(1)