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.
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
- Conditions the study is for
- Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
- 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
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.
7-hydroxystaurosporineDrug
prednisoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2002
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Giovanni Melillo, MD, Study chair, National Cancer Institute - Frederick
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas
- ClinicalTrials.gov ID
- NCT00045500
- Acronym / sponsor ID
- CDR0000256599
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Jan 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-hydroxystaurosporine | Drug | – |
| prednisone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Melillo, MD study chair
National Cancer Institute - Frederick
3 sites in 1 country: see every site and its status.
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.