NCT00045500

Brief Summary

RATIONALE: UCN-01 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining UCN-01 with prednisone may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with prednisone in treating patients who have refractory solid tumors or lymphoma.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

3 active sites

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

June 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

April 30, 2015

Status Verified

August 1, 2005

Enrollment Period

7.6 years

First QC Date

September 6, 2002

Last Update Submit

April 29, 2015

Conditions

LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

anaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomarecurrent adult Hodgkin lymphomarecurrent adult T-cell leukemia/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 cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent mantle cell lymphomaunspecified adult solid tumor, protocol specificrecurrent adult Burkitt lymphomarecurrent grade 3 follicular lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

7-hydroxystaurosporineDRUG
prednisoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor or lymphoma * Progressive disease after standard therapy * No other therapy is likely to improve survival * Prostate cancer patients must have progressed through hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists and withdrawal of testosterone receptor antagonists * Patients must continue on GnRH agonist during study (if orchiectomy has not been performed) and have castrate testosterone levels * Brain metastases allowed if treated and the patient has been stable off anti-seizure medication or steroids for \> 6 months * No local complications from disease requiring urgent therapy (i.e., hydronephrosis, spinal cord compression, or severe pain requiring improved pain management) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * 12-hour fasting glucose no greater than 110 mg/dL OR * 12-hour fasting glucose no greater than 140 mg/dL with hemoglobin A1C no greater than 6.5 mg/dL Hepatic * PT/PTT no greater than 1.5 times upper limit of normal (ULN) * Bilirubin no greater than 1.5 times ULN (unless Gilbert's syndrome present) * AST/ALT no greater than 2.5 times ULN Renal * Creatinine clearance greater than 60 mL/min OR * Creatinine no greater than 1.5 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris Pulmonary * No interstitial lung disease within the past year * No requirement for oxygen therapy for hypoxia in the past 6 months Gastrointestinal * No diagnosis of duodenal or gastric ulcer * No severe gastritis within the past 6 months Other * HIV negative * No prior allergic reactions to other indolocarbazoles * No diabetes or hyperglycemia within the past year that required a diabetic diet, oral hypoglycemics, or insulin * No other uncontrolled illness * No active infection * No seizure disorder * No psychiatric illness that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No prior UCN-01 Endocrine therapy * See Disease Characteristics * No other concurrent oral or IV steroids Radiotherapy * At least 4 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics * At least 21 days since prior major surgery Other * See Disease Characteristics * At least 4 weeks since prior investigational agents * No other concurrent anticancer therapy

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

Sponsors & Collaborators

Study Sites (3)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Frederick Cancer Research and Development Center

Frederick, Maryland, 21702-1201, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyIntraocular LymphomaHodgkin DiseasePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellBurkitt LymphomaLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

7-hydroxystaurosporinePrednisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphadenopathyEye NeoplasmsNeoplasms by SiteLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Giovanni Melillo, MD

    National Cancer Institute - Frederick

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

June 1, 2002

Primary Completion

January 1, 2010

Last Updated

April 30, 2015

Record last verified: 2005-08

Locations

US(3)