Lung CancerPhase 2NCT00003666
Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer
A Phase 2 study testing 6-hydroxymethylacylfulvene in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 48 sites 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 II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 6-hydroxymethylacylfulvene
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 48 sitesUnited States
- Study dates
- Nov 1998to Jan 2006
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically proven recurrent or refractory non-small cell lung cancer Squamous cell Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic (giant and clear cell carcinomas) Measurable disease (not bone disease only, pleural or pericardial effusions, or irradiated lesions, unless progression is documented after radiotherapy) No CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater 1.5 mg/dL SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than ULN Cardiovascular: No active cardiac disease No unstable angina No myocardial infarction within 6 months No congestive heart failure No inability to tolerate hypotension Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No uncontrolled diabetes mellitus No psychiatric disorders No concurrent secondary malignancies except nonmelanomatous skin cancer or patients with less than a 30% risk of relapse
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin) At least 1 prior chemotherapy agent or combination, including adjuvant or neoadjuvant therapy for non-small cell lung cancer No more than 1 prior chemotherapy agent or combination for metastatic or recurrent disease No prior HMAF No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except for nondisease related conditions Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: Not specified
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
CCOP - North Shore University Hospital
Manhasset, New York, 11030
North Shore University Hospital
Manhasset, New York, 11030
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38163
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021
Mount Sinai Medical Center, NY
New York, New York, 10029
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, 68105
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
Rhode Island Hospital
Providence, Rhode Island, 02903
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
Barnes-Jewish Hospital
St Louis, Missouri, 63110
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13210
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, 20007
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1082
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Determine the response rate to 6-hydroxymethylacylfulvene (HMAF) as salvage chemotherapy in patients with relapsed or refractory non-small cell lung cancer. II. Determine the duration of response to this regimen in this patient population. III. Determine the effect of prior response to chemotherapy on the response to HMAF in these patients. IV. Determine the survival and failure-free survival of patients treated with HMAF. V. Evaluate the toxicity profile of HMAF as salvage therapy in these patients.
OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of unacceptable toxic effects or disease progression. Patients are followed at least every 3 months for 1 year, then every 6 months until death.
PROJECTED ACCRUAL: A total of 66 patients (33 for each stratum) will be accrued for this study within 12-18 months.
- Conditions
- Lung Cancer
- Being tested
- 6-hydroxymethylacylfulvene
- Keywords
- recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-hydroxymethylacylfulveneDrug
Also called irofulven
11mg/sq m IV infusion over 5 min q day for 5 days each 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| HMAF | Experimental | treatment of refractory or relapsed NSCLC with HMAF Receives: Drug: 6-hydroxymethylacylfulvene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Measured: ea tx cycle; q 3 mon Yr 1 post tx, then q 6 mon until progression
Secondary outcomes (1)
Toxicity
Measured: Each tx cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2004 (estimated)
- Study startNov 1998
- Primary completionSep 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carol A. Sherman, MD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003666
- Sponsor's protocol ID
- CALGB-39805
- Other IDs
- U10CA031946, CLB-39805, CDR0000066761
- Status last verified
- Jul 2016
- First submitted
- 1 Nov 1999
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sherman CA, Herndon JE 2nd, Watson DM, Green MR; Cancer and Leukemia Group B. A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with relapsed or refractory non-small cell lung cancer. Lung Cancer. 2004 Sep;45(3):387-92. doi: 10.1016/j.lungcan.2004.02.017.
PubMed 15301880Sherman CA, Herndon JE, Green MR, et al.: CALGB 39805: phase II trial of 6-hydroxymethylacylfulvene (HMAF; MGI-114) in patients with relapsed or refractory non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2163, 2000.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00003666
- Acronym / sponsor ID
- CALGB-39805
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 1998
- Primary completion
- Sep 2004 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 13 Sep 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 II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer.
Detailed description
OBJECTIVES: I. Determine the response rate to 6-hydroxymethylacylfulvene (HMAF) as salvage chemotherapy in patients with relapsed or refractory non-small cell lung cancer. II. Determine the duration of response to this regimen in this patient population. III. Determine the effect of prior response to chemotherapy on the response to HMAF in these patients. IV. Determine the survival and failure-free survival of patients treated with HMAF. V. Evaluate the toxicity profile of HMAF as salvage therapy in these patients.
OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of unacceptable toxic effects or disease progression. Patients are followed at least every 3 months for 1 year, then every 6 months until death.
PROJECTED ACCRUAL: A total of 66 patients (33 for each stratum) will be accrued for this study within 12-18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMAF | Experimental | Drug: 6-hydroxymethylacylfulvenetreatment of refractory or relapsed NSCLC with HMAF |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| 6-hydroxymethylacylfulveneAlso: irofulven11mg/sq m IV infusion over 5 min q day for 5 days each 28 day cycle | Drug | HMAF |
Primary outcome
Response
Time frame: ea tx cycle; q 3 mon Yr 1 post tx, then q 6 mon until progression
1 secondary outcome
Toxicity
Time frame: Each tx cycle
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 20 Jul 2016.
- Results publication: PubMed 15301880Sherman CA, Herndon JE 2nd, Watson DM, Green MR; Cancer and Leukemia Group B. A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with relapsed or refractory non-small cell lung cancer. Lung Cancer. 2004 Sep;45(3):387-92. doi: 10.1016/j.lungcan.2004.02.017.
- Results publicationSherman CA, Herndon JE, Green MR, et al.: CALGB 39805: phase II trial of 6-hydroxymethylacylfulvene (HMAF; MGI-114) in patients with relapsed or refractory non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2163, 2000.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Carol A. Sherman, MD study chair
Medical University of South Carolina
48 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 6-hydroxymethylacylfulvene in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 48 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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?
Response (time frame: ea tx cycle; q 3 mon Yr 1 post tx, then q 6 mon until progression). 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 NCT00003666, which also lists 2 linked publications.
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 20 Jul 2016.