Drug ToxicityPhase 213-CisNCT00002586
13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer
A Phase 2 study testing 13-cis retinoic acid and Tocopherol in people with Drug Toxicity and Lung Cancer, run by University of Colorado, Denver at 4 sites in United States.
Trial summary
RATIONALE: 13 Cis retinoic acid may prevent the development of cancer cells. PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis retinoic acid with or without vitamin E for chemoprevention or observation of cancer in persons at high risk of developing lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Drug Toxicity, Lung Cancer
- What is being tested?
- 13-cis retinoic acid and Tocopherol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 1993to Dec 2005
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients identified through the Tissue Procurement/Screening Project with mild, moderate or severe dysplasia, Ca In situ OR surgically cured patients with head and neck cancer who are found to have mild atypia or greater on their staging bronchoscopy. (This includes carcinoma in situ). Also eligible are patients with Stage I and II non-small cell lung cancer who are disease free greater than 36 months.
- Patients must have at least a 30 pack year smoking history.
- Patients must be a current smoker or ex-smoker who have not smoked for at least 6 months more.
- Patients must have peripheral granulocyte count of > 1500 and platelet count of > 150,000.
- Patients must have adequate hepatic function with bilirubin < 1.5 mg % and SGPT < 4 times institutional upper limits of normal.
- Patients must have adequate renal function with serum creatinine < 1.5 mg %.
- All patients must be informed of the investigational nature of the study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Patients must not have a current or past history of cancer within the past 5 years with the exception of surgically cured head and neck cancer or surgically cured Stage I or II lung cancer > 36 months from diagnosis or skin cancer or in situ cancers.
- Patients must have no serious intercurrent illness including insulin dependent diabetes mellitus or hypercholesterolemia (>239mg/dl) / hypertriglyceridemia (>149mg/dl).
- Patients must not have evidence of clinically active coronary artery disease including myocardial infarction within 6 weeks, chest pain or poorly controlled congestive heart failure or any other serious medical condition, which would preclude a patient from undergoing a bronchoscopy.
- Patients must not have cardiac dysrhythmia that is potentially life threatening such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well controlled atrial fibrillation or rare (<2/minute) premature ventricular contractions are not exclusionary
- Chest x-ray must not show evidence of tumor.
- Patients must not be taking vitamin A or E supplements
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- Patients must not be taking tetracycline or minocycline.
- Patients who have had prior chemotherapy or radiation therapy.
- Women who are pregnant are ineligible
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
National Jewish Center for Immunology and Respiratory Medicine
Denver, Colorado, 80206
Lung Cancer Institute
Denver, Colorado, 80218
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
About this study
Official title: ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION
RATIONALE: 13 Cis retinoic acid may prevent the development of cancer cells.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis retinoic acid with or without vitamin E for chemoprevention or observation of cancer in persons at high risk of developing lung cancer.
Read the detailed description
OBJECTIVES:
- To determine if alpha tocopherol can reduce the toxicities of low dose 13-cis retinoic acid administered for one year.
- To access the adequacy of the collected specimens for studies of intermediate endpoint markers.
- to establish a depository of biologic specimens for future studies of new biomarkers.
- Arm 1: Patients receive oral 13-cis retinoic acid daily.
- Arm 2: Patients receive oral 13-cis retinoic acid and oral vitamin E daily.
- Arm 3: Patients undergo observation only. Treatment continues in arms I and II for 1 year in the absence of unacceptable toxicity.
Patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 100 patients (33 Arm 1, 33 Arm 2, and 34 Arm 3) will be accrued for this study within 3 years.
- Conditions
- Drug Toxicity, Lung Cancer
- Being tested
- 13-cis retinoic acid, Tocopherol
- Keywords
- non-small cell lung cancer, small cell lung cancer, drug/agent toxicity by tissue/organ
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-cis retinoic acidDrug
Also called Isotretinoin, AccutaneT
TocopherolDietary supplement
Also called Vitamin E
| Study group | Role | What they receive |
|---|---|---|
| 13-cis retinoic acid | Experimental | 13-cis retinoic acid 50 mg/d Receives: Drug: 13-cis retinoic acid |
| 13-Cis Retinoic Acid and Tocopherol | Experimental | 13-Cis Retinoic Acid (50 mg/day) Tocopherol (800 mg/day) Receives: Drug: 13-cis retinoic acid; Dietary Supplement: Tocopherol |
| Observation | No intervention | Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy
Measured: Three years
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 startJan 1993
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug ToxicityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- York E. Miller, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002586
- Sponsor's protocol ID
- 92-0382
- Other IDs
- NCI-V94-0506
- Acronym
- 13-Cis
- Status last verified
- May 2020
- First submitted
- 1 Nov 1999
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kelly K, Kittelson J, Franklin WA, Kennedy TC, Klein CE, Keith RL, Dempsey EC, Lewis M, Jackson MK, Hirsch FR, Bunn PA, Miller YE. A randomized phase II chemoprevention trial of 13-CIS retinoic acid with or without alpha tocopherol or observation in subjects at high risk for lung cancer. Cancer Prev Res (Phila). 2009 May;2(5):440-9. doi: 10.1158/1940-6207.CAPR-08-0136. Epub 2009 Apr 28.
PubMed 19401528
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION
- ClinicalTrials.gov ID
- NCT00002586
- Acronym / sponsor ID
- 13-Cis / 92-0382
- Conditions
- Drug Toxicity, Lung Cancer
- Keywords
- non-small cell lung cancer, small cell lung cancer, drug/agent toxicity by tissue/organ
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 1993
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (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: 13 Cis retinoic acid may prevent the development of cancer cells.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis retinoic acid with or without vitamin E for chemoprevention or observation of cancer in persons at high risk of developing lung cancer.
Detailed description
OBJECTIVES:
- To determine if alpha tocopherol can reduce the toxicities of low dose 13-cis retinoic acid administered for one year.
- To access the adequacy of the collected specimens for studies of intermediate endpoint markers.
- to establish a depository of biologic specimens for future studies of new biomarkers.
- Arm 1: Patients receive oral 13-cis retinoic acid daily.
- Arm 2: Patients receive oral 13-cis retinoic acid and oral vitamin E daily.
- Arm 3: Patients undergo observation only. Treatment continues in arms I and II for 1 year in the absence of unacceptable toxicity.
Patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 100 patients (33 Arm 1, 33 Arm 2, and 34 Arm 3) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 13-cis retinoic acid | Experimental | Drug: 13-cis retinoic acid13-cis retinoic acid 50 mg/d |
| 13-Cis Retinoic Acid and Tocopherol | Experimental | Drug: 13-cis retinoic acid, Dietary Supplement: Tocopherol13-Cis Retinoic Acid (50 mg/day) Tocopherol (800 mg/day) |
| Observation | No intervention | –Observation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients identified through the Tissue Procurement/Screening Project with mild, moderate or severe dysplasia, Ca In situ OR surgically cured patients with head and neck cancer who are found to have mild atypia or greater on their staging bronchoscopy. (This includes carcinoma in situ). Also eligible are patients with Stage I and II non-small cell lung cancer who are disease free greater than 36 months.
- Patients must have at least a 30 pack year smoking history.
- Patients must be a current smoker or ex-smoker who have not smoked for at least 6 months more.
- Patients must have peripheral granulocyte count of > 1500 and platelet count of > 150,000.
- Patients must have adequate hepatic function with bilirubin < 1.5 mg % and SGPT < 4 times institutional upper limits of normal.
Key exclusion criteria (9 listed)
- Patients must not have a current or past history of cancer within the past 5 years with the exception of surgically cured head and neck cancer or surgically cured Stage I or II lung cancer > 36 months from diagnosis or skin cancer or in situ cancers.
- Patients must have no serious intercurrent illness including insulin dependent diabetes mellitus or hypercholesterolemia (>239mg/dl) / hypertriglyceridemia (>149mg/dl).
- Patients must not have evidence of clinically active coronary artery disease including myocardial infarction within 6 weeks, chest pain or poorly controlled congestive heart failure or any other serious medical condition, which would preclude a patient from undergoing a bronchoscopy.
- Patients must not have cardiac dysrhythmia that is potentially life threatening such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well controlled atrial fibrillation or rare (<2/minute) premature ventricular contractions are not exclusionary
- Chest x-ray must not show evidence of tumor.
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 |
|---|---|---|
| 13-cis retinoic acidAlso: Isotretinoin, AccutaneT | Drug | 13-Cis Retinoic Acid and Tocopherol, 13-cis retinoic acid |
| TocopherolAlso: Vitamin E | Dietary supplement | 13-Cis Retinoic Acid and Tocopherol |
Primary outcome
Treatment failure
Time frame: Three years
Treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy
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 15 May 2020.
- Results publication: PubMed 19401528Kelly K, Kittelson J, Franklin WA, Kennedy TC, Klein CE, Keith RL, Dempsey EC, Lewis M, Jackson MK, Hirsch FR, Bunn PA, Miller YE. A randomized phase II chemoprevention trial of 13-CIS retinoic acid with or without alpha tocopherol or observation in subjects at high risk for lung cancer. Cancer Prev Res (Phila). 2009 May;2(5):440-9. doi: 10.1158/1940-6207.CAPR-08-0136. Epub 2009 Apr 28.
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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.
York E. Miller, MD principal investigator
University of Colorado, Denver
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 13-cis retinoic acid and Tocopherol in people with Drug Toxicity and Lung Cancer, run by University of Colorado, Denver at 4 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?
The sponsor lists 7 inclusion and 9 exclusion criteria. 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 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Treatment failure (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002586, which also lists 1 linked publication.
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 15 May 2020.