Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003250
Fenretinide in Treating Patients With Solid Tumors
A Phase 1 study testing fenretinide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating patients who have solid tumors. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- fenretinide
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 1998to Dec 2008
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven solid malignant tumors (carcinoma or sarcoma) Not eligible for any known treatment or regimen of higher potential efficacy No history of CNS tumors or prior CNS metastases
PATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/mL SGOT/SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/mL OR Creatinine clearance at least 60 mL/min Cardiovascular: At least 6 months since any acute myocardial infarction No congestive heart failure No New York Heart Association class III or IV heart disease No clinically significant cardiac arrhythmias Pulmonary: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No gastrointestinal bleeding or bleeding tendency
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: No prior systemic retinoid therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Phase I Evaluation of Fenretinide (NSC# 374551)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating patients who have solid tumors.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose and toxicity of oral fenretinide in patients with solid malignant tumors. II. Determine the pharmacokinetics of fenretinide and its metabolites. III. Determine the preliminary antitumor activity of fenretinide in this patient population. IV. Determine the recommended phase II starting dose of fenretinide. V. Determine whether fenretinide induces apoptosis in clinical specimens.
OUTLINE: This is a dose escalation study. Patients receive oral fenretinide once daily on days 1, 8 and 9 and three times a day on days 2-7. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Treatment continues for up to 6 months following complete remission. Accessible tumors are biopsied on day 8. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study within 6-9 months.
- Being tested
- fenretinide
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenretinideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose (MTD) and toxicities of 4-HPR
When drug is administered orally three times daily for 21 doses, repeated every 21 days.
Measured: per cycle
Secondary outcomes (1)
Characterize the pharmacokinetics of 4-HPR and its metabolite(s)
Measured: Pre-treatment; Cycle 1 Days 1 & 8: 1, 2, 4, 6, 8, 12, 24 hrs & day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2004 (estimated)
- Study startMay 1998
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patricia M. LoRusso, DO, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003250
- Sponsor's protocol ID
- CDR0000066130
- Other IDs
- U01CA062487, P30CA022453, WSU-C-1605, NCI-T97-0098
- Status last verified
- Apr 2014
- First submitted
- 1 Nov 1999
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Fenretinide (NSC# 374551)
- ClinicalTrials.gov ID
- NCT00003250
- Acronym / sponsor ID
- CDR0000066130
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1998
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 May 2004 (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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating patients who have solid tumors.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose and toxicity of oral fenretinide in patients with solid malignant tumors. II. Determine the pharmacokinetics of fenretinide and its metabolites. III. Determine the preliminary antitumor activity of fenretinide in this patient population. IV. Determine the recommended phase II starting dose of fenretinide. V. Determine whether fenretinide induces apoptosis in clinical specimens.
OUTLINE: This is a dose escalation study. Patients receive oral fenretinide once daily on days 1, 8 and 9 and three times a day on days 2-7. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Treatment continues for up to 6 months following complete remission. Accessible tumors are biopsied on day 8. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study within 6-9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| fenretinide | Drug | – |
Primary outcome
Determine the maximum tolerated dose (MTD) and toxicities of 4-HPR
Time frame: per cycle
When drug is administered orally three times daily for 21 doses, repeated every 21 days.
1 secondary outcome
Characterize the pharmacokinetics of 4-HPR and its metabolite(s)
Time frame: Pre-treatment; Cycle 1 Days 1 & 8: 1, 2, 4, 6, 8, 12, 24 hrs & day
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 11 Apr 2014.
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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.
Patricia M. LoRusso, DO study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fenretinide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Barbara Ann Karmanos Cancer Institute at 1 site 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Determine the maximum tolerated dose (MTD) and toxicities of 4-HPR (time frame: per cycle). It is what the study was designed to measure, not a finding.
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 11 Apr 2014.