Malignant NeoplasmPhase 1NCT00026169

Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure

A Phase 1 study testing imatinib mesylate, laboratory biomarker analysis and pharmacological study in people with Malignant Neoplasm and Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

Phase I trial to determine the dose of imatinib mesylate that is most effective with the least amount of toxic side effects in treating patients who have advanced cancer and kidney failure. Imatinib mesylate may stop the growth of cancer cells by stopping the enzyme necessary for cancer cell growth. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Malignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific
What is being tested?: imatinib mesylate, laboratory biomarker analysis and pharmacological study
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteUnited States
Study dates: Sep 2001to Apr 2005
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients must have histologically or cytologically confirmed malignancy, which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; the following tumor types are eligible:
(Note: All patients with normal renal function should be referred first to higher priority national trials under cooperative group or Novartis sponsorship; these studies include the Intergroup S0033 trial in GIST tumors and NABTC-9908 trial for gliomas; Novartis is also sponsoring ongoing clinical trials in pediatric patients with Philadelphia chromosome - positive acute lymphocytic leukemia and chronic myelogenous leukemia; for complete listing of other trials and sites collaborating investigators are encouraged to verify status of current national trials on the NCI - Physician Data Query [PDQ] system)
Patients with all hematological malignancies are eligible (such as myeloma, leukemia and lymphoma patients) provided the patient(s) have exhausted curative intent or life prolonging therapy and meet other eligibility in terms of blood counts; patients with Philadelphia chromosome - positive leukemia should be enrolled on other NCI or Novartis sponsored trials, if possible
Any solid tumor patient with abnormal renal dysfunction and including 12 patients with normal renal function (controls for pharmacokinetics) with an emphasis on patients with gastrointestinal stromal tumors (GIST) and including patients with glioma; patients with glioma who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for one month prior to enrollment
(Note: Slots will be retained for patients with CML or other Philadelphia chromosome-positive leukemia or GIST tumors beyond the initial dose level cohorts, since these tumor types have greater potential to respond to therapy); every effort should be made to enroll patients with glioma or GIST on available cooperative group trials first
Prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are allowed, including prior therapy with STI571; there is no ceiling on number of prior regimens

Show all 19Show fewer

ECOG performance status =< 2, (Karnofsky >= 60%) and a life expectancy of at least 3 months
Leukocytes >= 3,000/uL, OR
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
Total bilirubin within normal institutional limits
AST (SGOT)/ALT (SGPT) =< 1.5 times the institutional upper limit of normal
Patients with abnormal kidney function will be allowed and will be grouped accordingly
Patients with gliomas and brain metastases, who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for one month prior to enrollment; patients with brain metastasis should have had brain irradiation
The effects of STI571 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because STI571 is known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; since interaction with STI571 and oral contraceptives is possible, a barrier method should be used and oral contraceptives should not be the only method; a negative pregnancy test is required prior to starting therapy for women of child bearing age; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Pregnancy: STI571 may be harmful to the developing fetus; therefore, for patients enrolled on the study, contraceptive methods are recommended, and since interactions with the metabolism of some oral contraceptives cannot be excluded at present, an additional or alternative effective method of contraception, (e.g., barrier method) should be used
Breast feeding: STI571 may be harmful to nursing infants secondary to STI571 treatment of the mother' breastfeeding should be discontinued if the mother is treated with STI571
Ability to understand and the willingness to sign a written informed consent form
Patients must be capable of following instructions regarding study medication, completion of medication diaries, or have a caregiver who will be responsible for administering study medication and completing medication diaries

Who cannot join

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study enrollment (excluding hydroxyurea if hydroxyurea was administered to patients with leukemia to maintain a lower WBC count); in the case of leukemic patients on maintenance hydroxyurea, patients may not receive hydroxyurea within 24 hours prior to initiation of therapy
Patients undergoing therapy with other investigational agents; patients on therapeutic doses of warfarin are excluded
Patients who have had liver, kidney, lung transplants or taking FK-506, cyclosporine as an immunosuppressive agent; these agents may cause increased toxicity with STI571
Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant and nursing women are excluded from this study because STI571 is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with STI571, breastfeeding should be discontinued if the mother is treated with STI571
Because patients with immune deficiency are at increased risk of lethal infections, when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with STI571

Show all 9Show fewer

Patients receiving renal dialysis treatments while on the study will be enrolled in two cohorts per the schema
Patients must not have had a major surgery (e.g., thoracotomy, intra-abdominal surgery) within 14 days prior to registration
Patients with unstable or untreated (irradiated) brain metastases should be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

Case Western Reserve University
Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group

Read the detailed description

PRIMARY OBJECTIVES:

To establish the maximum tolerated dose (MTD) of STI571 for cohorts of patients with varying degrees of renal dysfunction (normal, mild, moderate, and severe).

II. To determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of STI571.

III. To evaluate the safety of STI571 in patients with various degrees of renal dysfunction.

OUTLINE: This is a dose-escalation study. Patients are stratified according to creatinine clearance (at least 60 mL/min vs 40-59 mL/min vs 20-39 mL/min vs less than 20 mL/min vs any creatinine clearance and undergoing dialysis).

Patients receive oral imatinib mesylate once or twice daily on days 1 and 4-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients in each stratum receive escalating doses of imatinib mesylate 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.

PROJECTED ACCRUAL: Approximately 60-69 patients (about 12 per stratum) will be accrued for this study.

Conditions: Malignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific
Being tested: imatinib mesylate, laboratory biomarker analysis, pharmacological study
Medical subject headings: Neoplasms

What participants receive

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

imatinib mesylateDrug
Also called CGP 57148, Gleevec, Glivec
Given orally
laboratory biomarker analysisOther
Correlative studies
pharmacological studyOther
Also called pharmacological studies
Correlative studies

Study groups in NCT00026169
Study group	Role	What they receive
Treatment (imatinib mesylate)	Experimental	Patients receive oral imatinib mesylate once or twice daily on days 1 and 4-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in each stratum receive escalating doses of imatinib mesylate until the 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. Receives: Drug: imatinib mesylate; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum tolerated dose (MTD) of imatinib mesylate, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Toxicities will be tabulated and summarized by organ systems.
Measured: Up to 4 weeks

Secondary outcomes (3)

Estimates of incidences of adverse events and dose limiting toxicity (DLT), based on the NCI CTC v2.0
Measured: Up to 7 years
Pharmacokinetic parameters
Measured: Up to day 16
Response rates based on the Response Evaluation Criteria in Solid Tumors
Estimated along with confidence intervals based on exact binomial probabilities.
Measured: Up to 7 years

Timeline

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

Sep 2001Apr 2005

First posted27 Jan 2003 (estimated)
Study startSep 2001
Primary completionApr 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Malignant NeoplasmStudies 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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 69 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00026169
Sponsor's protocol ID: NCI-2012-03115
Other IDs: CWRU 1Y01, U01CA062487, U01CA062505, U01CA069853, U01CA062502, U01CA062491, U01CA099168
Status last verified: Jan 2013
First submitted: 9 Nov 2001
Last updated: 10 Jan 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm

All Malignant Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group
ClinicalTrials.gov ID: NCT00026169
Acronym / sponsor ID: NCI-2012-03115
Conditions: Malignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (estimated)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Sep 2001
Primary completion: Apr 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.

Detailed description

PRIMARY OBJECTIVES:

To establish the maximum tolerated dose (MTD) of STI571 for cohorts of patients with varying degrees of renal dysfunction (normal, mild, moderate, and severe).

II. To determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of STI571.

III. To evaluate the safety of STI571 in patients with various degrees of renal dysfunction.

Patients receive oral imatinib mesylate once or twice daily on days 1 and 4-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 60-69 patients (about 12 per stratum) will be accrued for this study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (imatinib mesylate)	Experimental	Drug: imatinib mesylate, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive oral imatinib mesylate once or twice daily on days 1 and 4-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in each stratum receive escalating doses of imatinib mesylate until the 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (19 listed)

Patients must have histologically or cytologically confirmed malignancy, which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; the following tumor types are eligible:
Prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are allowed, including prior therapy with STI571; there is no ceiling on number of prior regimens
ECOG performance status =< 2, (Karnofsky >= 60%) and a life expectancy of at least 3 months
Leukocytes >= 3,000/uL, OR
Absolute neutrophil count >= 1,500/uL

Key exclusion criteria (9 listed)

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study enrollment (excluding hydroxyurea if hydroxyurea was administered to patients with leukemia to maintain a lower WBC count); in the case of leukemic patients on maintenance hydroxyurea, patients may not receive hydroxyurea within 24 hours prior to initiation of therapy
Patients undergoing therapy with other investigational agents; patients on therapeutic doses of warfarin are excluded
Patients who have had liver, kidney, lung transplants or taking FK-506, cyclosporine as an immunosuppressive agent; these agents may cause increased toxicity with STI571
Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant and nursing women are excluded from this study because STI571 is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with STI571, breastfeeding should be discontinued if the mother is treated with STI571

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
imatinib mesylateAlso: CGP 57148, Gleevec, GlivecGiven orally	Drug	Treatment (imatinib mesylate)
laboratory biomarker analysisCorrelative studies	Other	Treatment (imatinib mesylate)
pharmacological studyAlso: pharmacological studiesCorrelative studies	Other	Treatment (imatinib mesylate)

Primary outcome

Maximum tolerated dose (MTD) of imatinib mesylate, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Time frame: Up to 4 weeks
Toxicities will be tabulated and summarized by organ systems.

3 secondary outcomes

Estimates of incidences of adverse events and dose limiting toxicity (DLT), based on the NCI CTC v2.0
Time frame: Up to 7 years
Pharmacokinetic parameters
Time frame: Up to day 16
Response rates based on the Response Evaluation Criteria in Solid Tumors
Time frame: Up to 7 years

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 10 Jan 2013.

Related trials for Malignant Neoplasm

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm

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.

Afshin Dowlati principal investigator

Case Western Reserve University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 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 10 Jan 2013. 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?

Maximum tolerated dose (MTD) of imatinib mesylate, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 (time frame: Up to 4 weeks). 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 NCT00026169.

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 10 Jan 2013.