NCT00293488

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in treating patients with relapsed or refractory lymphoma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

2.7 years

First QC Date

February 16, 2006

Last Update Submit

June 21, 2016

Conditions

Lymphoma

Keywords

anaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent mycosis fungoides/Sezary syndromesplenic marginal zone lymphoma

Interventions

polyamine analogue PG11047DRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically\* confirmed Hodgkin's or non-Hodgkin's lymphoma (NHL) of any histology * The following NHL types are eligible: * Diffuse large B-cell lymphoma * Follicular lymphoma * Mantle Cell lymphoma * Marginal zone lymphoma (including lymphoma of mucosa-associated tissue \[MALT\]) * Anaplastic large cell lymphoma * Peripheral T-cell lymphoma * Cutaneous T-cell lymphoma * T/NK cell lymphoma * Angioimmunoblastic lymphadenopathy-type T-cell lymphoma * Burkitt's lymphoma NOTE: \* If histologic confirmation was made at initial diagnosis, confirmation of relapsed or refractory disease can be made by repeat histologic evaluation OR by evidence of regrowth at a site of disease that was previously histologically confirmed * Relapsed after or refractory to ≥ 2 prior therapeutic regimens OR patient is ineligible to receive potentially curative therapy * Bidimensionally measurable or evaluable (e.g., bone marrow or infiltrative organ involvement) disease by physical exam or radiographic study * No suspicion or evidence of lymphomatous meningitis PATIENT CHARACTERISTICS: * Life expectancy ≥ 12 weeks * ECOG performance status 0-4 * Not pregnant * Negative pregnancy test * Fertile patients must use medically prescribed contraception * Absolute neutrophil count ≥ 1,000/mm\^3\* * Platelet count ≥ 50,000/mm\^3\* * Hemoglobin ≥ 8 g/dL\* * Serum creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 2.0 mg/dL\*\* * Transaminases \< 5 times upper limit of normal\*\* * No other malignancy within the past 5 years other than curatively treated non-metastatic skin cancer or in situ cervical carcinoma * No history of significant or symptomatic cardiac arrhythmia * No history of myocardial infarction * No significant ventricular conduction abnormality by ECG or Holter monitoring, as evidenced by any of the following: * Prior myocardial infarction * Three or more premature ventricular contractions in a row * No history of pancreatitis * No history of recent gastrointestinal bleeding * Must have heme-negative stool at enrollment NOTE: \*Cytopenias due to direct lymphomatous involvement allowed NOTE: \*\*Elevated due to direct lymphomatous involvement allowed PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 3 weeks since prior chemotherapy * Recovered from prior chemotherapy (alopecia or anemia allowed) * More than 3 weeks since prior investigational drugs * No prophylactic antiemetics during course 1 * No other concurrent investigational drugs

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

Sponsors & Collaborators

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseHodgkin DiseasePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary Syndrome

Interventions

(N(1),N(12))bis(ethyl)-6,7-dehydrospermine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-HodgkinLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaHematologic Diseases

Study Officials

  • Barbara Hicks

    Progen Pharmaceuticals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 17, 2006

Study Start

January 1, 2006

Primary Completion

September 1, 2008

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

US(1)