Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00119236
17-AAG and Irinotecan in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing tanespimycin and irinotecan hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I trial is studying the side effects and best dose of 17-AAG and irinotecan in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as 17-AAG and irinotecan, work in different ways to stop the growth of tumor cells either by killing the cells or by stopping… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- tanespimycin and irinotecan hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed solid tumor, excluding primary CNS tumors
- Locally advanced or metastatic disease that is refractory to standard therapy OR for which no standard therapy exists
- Tumor assessible for biopsy by Tru-cut^®, CT guidance, or endoscopy (for patients treated at the maximum tolerated dose [expanded cohort only])
- Pleural effusions or abdominal ascites are not considered biopsy-accessible tissue
- No known new CNS metastases that have not been previously treated
- Performance status - Karnofsky 60-100%
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- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Creatinine ≤ 1.5 mg/dL
- No history of cardiac arrhythmias
- No myocardial infarction within the past 12 months
- No active ischemic heart disease within the past 12 months
- No New York Heart Association class III-IV congestive heart failure or LVEF < 40% by MUGA
- No history of uncontrolled cardiac dysrhythmia or dysrhthmias requiring medication
- No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- No congenital long QT syndrome
- No left bundle branch block
- QTc < 450 msec (for male patients)
- QTc < 470 msec (for female patients)
- Not pregnant
- No nursing during and for 2 months after study participation
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- No serious or uncontrolled infection
- No history of serious allergic reaction to eggs or egg products
- No other medical condition that would preclude study participation
- At least 3 weeks since prior immunotherapy
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- Prior irinotecan allowed
- No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
- At least 2 weeks since prior non-myelosuppressive chemotherapy (at the discretion of the principal investigator)
- At least 3 weeks since prior radiotherapy
- No prior radiotherapy field that included the heart (e.g., mantle)
- Recovered from all prior therapy
- At least 3 weeks since prior anticancer investigational therapeutic drugs
- More than 7 days since prior and no concurrent inducers, inhibitors, or modifiers of CYP3A4, including any of the following:
- Fluconazole
- Itraconazole
- Ketoconazole
- Azithromycin
- Clarithromycin
- Erythromycin
- Troleandomycin
- Nifedipine
- Verapamil
- Diltiazem
- Nefazodone
- Cyclosporine
- Grapefruit juice (> 1 quart/day)
- Indinavir
- Nelfinavir
- Ritonavir
- Saquinavir
- Carbamazepine
- Phenobarbital
- Phenytoin
- Rifampin
- Hydrastis canadensis (goldenseal)
- Hypericum perforatum (St. John's wort)
- Uncaria tomentosa (cat's claw)
- Echinacea angustifolia root
- Trifolium pratense (wild cherry)
- Matricaria chamomila (chamomile)
- Glycyrrhiza glabra (licorice)
- Dillapiol
- Hypericin
- Naringenin
- No concurrent medications that would prolong QTc
- No concurrent vitamins, antioxidants, herbal preparations, or supplements
- Concurrent single daily multivitamin allowed
- No other concurrent anticancer therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational medications
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: An Open-Labeled Non-Randomized Phase I Study of 17-N-allylamino-17-demethoxy Geldanamycin (17AAG) Administered With Irinotecan (CPT-11) in Patients With Advanced Solid Tumors
This phase I trial is studying the side effects and best dose of 17-AAG and irinotecan in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as 17-AAG and irinotecan, work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of combined 17AAG and irinotecan given weekly for two weeks in a 21-day cycle that can be used for future phase II studies.
SECONDARY OBJECTIVES:
- To explore the effects of the combination on the expression of Hsp90 client proteins in peripheral mononuclear cells and tumor tissues. Tumor biopsies will be performed before and after 17AAG treatment in 12 patients at the MTD ("Expanded Cohort") only.
II. To investigate the clinical pharmacokinetics of intravenous 17AAG, irinotecan, and their metabolites, in this combination.
III. To obtain preliminary data on the therapeutic activity of 17AAG in combination with irinotecan in patients with advanced solid tumors.
IV. To obtain preliminary result in the relationship between tumor response and p53-status.
OUTLINE: This is an open-label, non-randomized, dose-escalation study.
Patients receive irinotecan IV over 30 minutes followed by 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)* IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or improved disease after course 2 may receive additional courses of treatment.
NOTE: *17-AAG is administered on days 2 and 8 during course 2 for patients treated at non-maximum tolerated doses (MTD) (dose-escalation portion) and on day 8 only during course 1 for patients treated at the MTD (expanded cohort).Cohorts of 3-6 patients receive escalating doses of 17-AAG and irinotecan until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 12 patients are treated at the MTD.
- Being tested
- tanespimycin, irinotecan hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tanespimycinDrug
Also called 17-AAG
Also called Campto, Camptosar, CPT-11, irinotecan
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive irinotecan IV over 30 minutes followed by 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)* IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or improved disease after course 2 may receive additional courses of treatment. Receives: Drug: tanespimycin; Drug: irinotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose determined by dose-limiting toxicities
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startMay 2005
- Primary completionOct 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.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Archie Tse, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119236
- Sponsor's protocol ID
- NCI-2012-01467
- Other IDs
- 05-017, MSKCC-IRB-05017, NCI-7009, CDR0000434501, U01CA069856
- Status last verified
- Jun 2013
- First submitted
- 12 Jul 2005
- Last updated
- 4 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled Non-Randomized Phase I Study of 17-N-allylamino-17-demethoxy Geldanamycin (17AAG) Administered With Irinotecan (CPT-11) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00119236
- Acronym / sponsor ID
- NCI-2012-01467
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2005
- Primary completion
- Oct 2008 (actual)
- First posted
- 13 Jul 2005 (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.
This phase I trial is studying the side effects and best dose of 17-AAG and irinotecan in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as 17-AAG and irinotecan, work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of combined 17AAG and irinotecan given weekly for two weeks in a 21-day cycle that can be used for future phase II studies.
SECONDARY OBJECTIVES:
- To explore the effects of the combination on the expression of Hsp90 client proteins in peripheral mononuclear cells and tumor tissues. Tumor biopsies will be performed before and after 17AAG treatment in 12 patients at the MTD ("Expanded Cohort") only.
II. To investigate the clinical pharmacokinetics of intravenous 17AAG, irinotecan, and their metabolites, in this combination.
III. To obtain preliminary data on the therapeutic activity of 17AAG in combination with irinotecan in patients with advanced solid tumors.
IV. To obtain preliminary result in the relationship between tumor response and p53-status.
OUTLINE: This is an open-label, non-randomized, dose-escalation study.
Patients receive irinotecan IV over 30 minutes followed by 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)* IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or improved disease after course 2 may receive additional courses of treatment.
NOTE: *17-AAG is administered on days 2 and 8 during course 2 for patients treated at non-maximum tolerated doses (MTD) (dose-escalation portion) and on day 8 only during course 1 for patients treated at the MTD (expanded cohort).Cohorts of 3-6 patients receive escalating doses of 17-AAG and irinotecan until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 12 patients are treated at the MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: tanespimycin, Drug: irinotecan hydrochloridePatients receive irinotecan IV over 30 minutes followed by 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)* IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or improved disease after course 2 may receive additional courses of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (77 listed)
- Histologically confirmed solid tumor, excluding primary CNS tumors
- Tumor assessible for biopsy by Tru-cut^®, CT guidance, or endoscopy (for patients treated at the maximum tolerated dose [expanded cohort only])
- No known new CNS metastases that have not been previously treated
- Performance status - Karnofsky 60-100%
- WBC ≥ 3,000/mm^3
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| tanespimycinAlso: 17-AAG | Drug | Arm I |
| irinotecan hydrochlorideAlso: Campto, Camptosar, CPT-11, irinotecan | Drug | Arm I |
Primary outcome
Maximum tolerated dose determined by dose-limiting toxicities
Time frame: 21 days
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 4 Jun 2013.
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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.
Archie Tse principal investigator
Memorial Sloan Kettering Cancer Center
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 tanespimycin and irinotecan hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) 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?
The sponsor lists 77 inclusion and 0 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 4 Jun 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 determined by dose-limiting toxicities (time frame: 21 days). 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 4 Jun 2013.