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LymphomaPhase 1NCT00045500

UCN-01 and Prednisone in Treating Patients With Solid Tumors or Lymphoma

A Phase 1 study testing 7-hydroxystaurosporine and prednisone in people with Lymphoma and Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
7-hydroxystaurosporine and prednisone
How many people
Not given
Where
3 sitesUnited States
Study dates
Jun 2002to Jan 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • NCI - Center for Cancer Research

    Bethesda, Maryland, 20892

  • Frederick Cancer Research and Development Center

    Frederick, Maryland, 21702-1201

Other trials in United States

About this study

Official title: A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas

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.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of UCN-01 in combination with prednisone in patients with refractory solid tumors or lymphomas.
  • Determine the toxic effects of this regimen in these patients.
  • Assess the pharmacokinetics of this regimen in these patients.
  • Assess any tumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of UCN-01.

Patients receive oral prednisone daily on days 1-5 and UCN-01 IV over 36-72 hours on days 3-5. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the recommended phase II dose.

Patients are followed every 3-12 months for 5 years.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 18 months.

Being tested
7-hydroxystaurosporine, prednisone
Keywords
anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, intraocular lymphoma, primary central nervous system non-Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent mantle cell lymphoma, unspecified adult solid tumor, protocol specific, recurrent adult Burkitt lymphoma, recurrent grade 3 follicular lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Intraocular Lymphoma, Hodgkin Disease, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2002
  3. Primary completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00045500
Sponsor's protocol ID
CDR0000256599
Other IDs
NCI-02-C-0241, NCI-5694
Status last verified
Aug 2005
First submitted
6 Sep 2002
Last updated
30 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 7-hydroxystaurosporine and prednisone in people with Lymphoma and Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.

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