Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00004919
Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
A Phase 1 study testing cisplatin, irinotecan hydrochloride and amifostine trihydrate in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- cisplatin, irinotecan hydrochloride and amifostine trihydrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Mar 2003
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- STRATUM I INCLUSION:
- Each patient must have a proven pathologic diagnosis of solid tumor; the tumor must be refractory to conventional therapies, or for which no effective therapy is known; patients with brain tumors are eligible, but they should not be receiving anticonvulsants; the requirement for histologic diagnosis can be waived for patients with brainstem gliomas
- Karnofsky >= 50% for patients > 10 years of age; Lansky play scale >= 50% for children =< 10 years of age; neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 2 weeks prior to study entry; patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score
- Life expectancy >= 8 weeks
- Nutrition status >= 3rd percentile weight for height and serum albumin >= 2.5 g%
- Prior therapy: patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, and must be without significant systemic illness (e.g., infection, fever, mucositis, severe anorexia, and severe malnutrition)
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- Myelosuppressive chemotherapy must not have been received within 3 weeks of entry on this study (six weeks if a prior nitrosourea)
- Biologic, anti-neoplastic agents must not have received at least 1 week
- Radiation >= 2 weeks must have been elapsed from prior local radiation (small port); >= 6 months must have been elapsed from prior craniospinal radiation or >= 50% radiation of the pelvis; 6 weeks must have been elapsed from substantial bone marrow radiation
- Autologous or allogeneic BMT without TBI >= 6 months must have been elapsed, with no evidence of GVH disease
- Growth factor(s) must not have been received within one week of entry on this study
- Steroids: patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 2 weeks prior to study entry
- ANC >= 1,000/ul
- Hemoglobin >= 8.0 g/dL
- Platelet count >= 100,000/ul
- Bilirubin =< 1.5 mg/dL
- SGPT =< 2 times upper limit of normal
- Albumin >= 2.5 g/dL
- Normal serum creatinine for age or, if abnormal serum creatinine, normal GFR for age
- All patients (or their legal guardians if patient is less than 18 years of age) must sign a document of informed consent that has been approved by the Institutional Human Review Committee; when appropriate the patient will be included in all discussions in order to obtain verbal assent
- The Phase I Office must give permission to register the patient; registration must occur on the day the patient receives the treatment; however, the registration should precede the drug administration
- Protocol must be approved by the local Institutional Review Board (IRB) prior to any patient registration and reapproved every twelve months
Who cannot join
- STRATUM I EXCLUSION:
- Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Patients who have uncontrolled infections are not eligible for this study
- Patients who are receiving any other chemotherapy or investigational agents are not eligible for this study
- Patients who are receiving anticonvulsants are not eligible for this study
- STRATUM II EXCLUSION:
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- Patients who have received more than two prior chemotherapy regimens (single or multi-agent regimens)
- Patients who have had central axis radiation
- Patients with bone marrow involvement
- Patients who have had prior stem cell transplantation (with or without TBI)
Trial locations and contacts
1 site in 1 country.
United States1 site
COG Phase I Consortium
Arcadia, California, 91006-3776
About this study
Official title: A Trial of Irinotecan and Cisplatin in Children With Refractory Solid Tumors
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. Phase I trial to study the effectiveness of irinotecan and cisplatin with or without amifostine in treating children who have solid tumors that have not responded to previous therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of irinotecan when administered with cisplatin, with or without amifostine, to children with refractory solid tumors.
II. Determine the dose limiting toxicities of the combination of irinotecan and cisplatin, with and without amifostine, in this patient population.
III. Determine the pharmacokinetics of cisplatin with and without amifostine in these patients.
IV. Quantify the leukocyte DNA-platinum adduct formation, with and without amifostine, and correlate it with response and toxicity in these patients.
- Determine the safety and efficacy of the doses and schedules of administration to be used in phase II clinical trials.
OUTLINE: This is a dose escalation study of irinotecan.
Treatment A: Patients receive cisplatin IV over 1 hour followed immediately by irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 6 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
Treatment B: Patients receive therapy as in treatment A. In addition, amifostine IV is administered over 15 minutes immediately before cisplatin.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (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 toxicities. Once the MTD of treatment A is determined, additional patients are accrued to determine the MTD of treatment B.
If myelosuppression is the dose limiting toxicity of treatment A, then stratum 1 closes and stratum 2 opens and these patients with less prior therapy receive treatment A. Treatment B is then only open to stratum 3 patients.
Patients are followed every 6 months for 4 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2.5 years.
- Being tested
- cisplatin, irinotecan hydrochloride, amifostine trihydrate, pharmacological study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
Also called Campto, Camptosar, CPT-11, irinotecan
Given IV
amifostine trihydrateDrug
Also called ethiofos, Ethyol, gammaphos, WR-2721
Given IV
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cisplatin, irinotecan, amifostine) | Experimental | Treatment A: Patients receive cisplatin IV over 1 hour followed immediately by irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 6 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
Treatment B: Patients receive therapy as in treatment A. In addition, amifostine IV is administered over 15 minutes immediately before cisplatin. Receives: Drug: cisplatin; Drug: irinotecan hydrochloride; Drug: amifostine trihydrate; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD defined as that dose level immediately below the dose level at which 2 patients out of 3 to 6 patients experienced dose-limiting toxicity using Common Toxicity Criteria version 2.0
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2004 (estimated)
- Study startDec 1999
- Primary completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Childhood 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Abdul-Kader Souid, Principal investigator, COG Phase I Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004919
- Sponsor's protocol ID
- NCI-2012-01846
- Other IDs
- P9970, CDR0000067601, CCG-P9970, U01CA097452
- Status last verified
- Jul 2013
- First submitted
- 7 Mar 2000
- Last updated
- 2 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Irinotecan and Cisplatin in Children With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00004919
- Acronym / sponsor ID
- NCI-2012-01846
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 1999
- Primary completion
- Mar 2003 (actual)
- First posted
- 12 Feb 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.
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. Phase I trial to study the effectiveness of irinotecan and cisplatin with or without amifostine in treating children who have solid tumors that have not responded to previous therapy.
Detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of irinotecan when administered with cisplatin, with or without amifostine, to children with refractory solid tumors.
II. Determine the dose limiting toxicities of the combination of irinotecan and cisplatin, with and without amifostine, in this patient population.
III. Determine the pharmacokinetics of cisplatin with and without amifostine in these patients.
IV. Quantify the leukocyte DNA-platinum adduct formation, with and without amifostine, and correlate it with response and toxicity in these patients.
- Determine the safety and efficacy of the doses and schedules of administration to be used in phase II clinical trials.
OUTLINE: This is a dose escalation study of irinotecan.
Treatment A: Patients receive cisplatin IV over 1 hour followed immediately by irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 6 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
Treatment B: Patients receive therapy as in treatment A. In addition, amifostine IV is administered over 15 minutes immediately before cisplatin.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (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 toxicities. Once the MTD of treatment A is determined, additional patients are accrued to determine the MTD of treatment B.
If myelosuppression is the dose limiting toxicity of treatment A, then stratum 1 closes and stratum 2 opens and these patients with less prior therapy receive treatment A. Treatment B is then only open to stratum 3 patients.
Patients are followed every 6 months for 4 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cisplatin, irinotecan, amifostine) | Experimental | Drug: cisplatin, Drug: irinotecan hydrochloride, Drug: amifostine trihydrate, Other: pharmacological studyTreatment A: Patients receive cisplatin IV over 1 hour followed immediately by irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 6 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Treatment B: Patients receive therapy as in treatment A. In addition, amifostine IV is administered over 15 minutes immediately before cisplatin. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- STRATUM I INCLUSION:
- Each patient must have a proven pathologic diagnosis of solid tumor; the tumor must be refractory to conventional therapies, or for which no effective therapy is known; patients with brain tumors are eligible, but they should not be receiving anticonvulsants; the requirement for histologic diagnosis can be waived for patients with brainstem gliomas
- Karnofsky >= 50% for patients > 10 years of age; Lansky play scale >= 50% for children =< 10 years of age; neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 2 weeks prior to study entry; patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score
- Life expectancy >= 8 weeks
- Nutrition status >= 3rd percentile weight for height and serum albumin >= 2.5 g%
Key exclusion criteria (10 listed)
- STRATUM I EXCLUSION:
- Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Patients who have uncontrolled infections are not eligible for this study
- Patients who are receiving any other chemotherapy or investigational agents are not eligible for this study
- Patients who are receiving anticonvulsants are not eligible for this study
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 |
|---|---|---|
| cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV | Drug | Treatment (cisplatin, irinotecan, amifostine) |
| irinotecan hydrochlorideAlso: Campto, Camptosar, CPT-11, irinotecanGiven IV | Drug | Treatment (cisplatin, irinotecan, amifostine) |
| amifostine trihydrateAlso: ethiofos, Ethyol, gammaphos, WR-2721Given IV | Drug | Treatment (cisplatin, irinotecan, amifostine) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (cisplatin, irinotecan, amifostine) |
Primary outcome
MTD defined as that dose level immediately below the dose level at which 2 patients out of 3 to 6 patients experienced dose-limiting toxicity using Common Toxicity Criteria version 2.0
Time frame: 6 weeks
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 2 Jul 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.
Abdul-Kader Souid principal investigator
COG Phase I Consortium
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 cisplatin, irinotecan hydrochloride and amifostine trihydrate in people with Unspecified Childhood 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 22 inclusion and 10 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 2 Jul 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?
MTD defined as that dose level immediately below the dose level at which 2 patients out of 3 to 6 patients experienced dose-limiting toxicity using Common Toxicity Criteria version 2.0 (time frame: 6 weeks). 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 2 Jul 2013.