Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia
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| ClinicalTrials.gov Identifier: NCT00900445 |
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Recruitment Status :
Withdrawn
First Posted : May 12, 2009
Last Update Posted : August 7, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia | Drug: Daunorubicin Hydrochloride Other: Pharmacological Study Drug: Prednisolone Drug: Prednisone Drug: Vincristine Sulfate |
PRIMARY OBJECTIVES:
I. To compare the pharmacokinetics of prednisone/prednisolone, vincristine, and daunorubicin hydrochloride among obese, middle-weight, and underweight children aged 10 to less than 20 years of age undergoing induction therapy for high-risk acute lymphoblastic leukemia.
II. To examine the relationship between the above parameters and response status as defined by early response and induction failure
OUTLINE: This is a multicenter study. Patients are stratified according to body mass index (BMI) (greater than or equal to 95th percentile [obese] vs 10th to 95th percentile [normal or at risk for overweight] vs less than or equal to 10th percentile [underweight]).
Patients receive anticancer therapy as prescribed by their treating clinicians. Patients receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.
Blood samples are obtained on either day 1 or day 8** of induction therapy for pharmacokinetic analysis of prednisone, daunorubicin hydrochloride, and vincristine activity levels.
Blood samples are analyzed via high-performance liquid chromatography (HPLC), ultrafiltration, a Nessler reaction, ELISA, and liquid chromatography using reverse-phase chromatography, fluorescent detection, and solid-phase extraction.
Demographic information, including ethnicity, is also collected. Weight and height is recorded at diagnosis and on the day pharmacokinetic assessment of vincristine, prednisone, and daunorubicin hydrochloride begins.
NOTE: **Patients who are being sampled on day 8 of induction therapy and who have received intravenous corticosteroid therapy in the first week of induction must have received at least six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone dose on day 8.
| Study Type : | Observational |
| Actual Enrollment : | 0 participants |
| Official Title: | Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL) |
| Actual Study Start Date : | March 24, 2008 |
| Actual Primary Completion Date : | August 17, 2009 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Basic science (pharmacokinetics)
Patients receive anticancer therapy as prescribed by their treating clinicians. Patients receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.
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Drug: Daunorubicin Hydrochloride
Given IV
Other Names:
Other: Pharmacological Study Correlative studies Drug: Prednisolone Given orally
Other Names:
Drug: Prednisone Given orally
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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- Pharmacokinetic parameters of prednisone/prednisolone [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours ]Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
- Pharmacokinetic parameters of daunorubicin hydrochloride [ Time Frame: Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours ]Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
- Pharmacokinetic parameters of vincristine sulfate [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours ]Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
- RER and SER status [ Time Frame: Up to 1.5 years ]To examine the relationship between pharmacokinetic parameters and RER versus SER status, univariate and multiple logistic regressions will be performed.
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| Ages Eligible for Study: | 10 Years to 19 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients must be newly diagnosed with acute lymphoblastic leukemia and the intended induction treatment must contain prednisone/prednisolone, vincristine and daunorubicin in the doses and schedule as per the current COG AALL0232 protocol; prior registration onto a COG protocol is not required
- Patients must be able to take either prednisone/prednisolone reliably by mouth on day 1 or 8 of induction (depending on sampling schedule chosen); patients who are being sampled on Induction day 8 and who have received intravenous corticosteroid therapy in the first week of induction must have received a minimum of six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone dose on induction day 8
Exclusion Criteria:
- Serum transaminase concentrations >= 5 X ULN for age
- Total serum bilirubin (conjugated + unconjugated) >= 1.5 mg/dl (>= 26 micromol/L)
- Serum creatinine > 1.5 X ULN for age
- With the exception of prednisone/prednisolone, receipt of medications or food known or with the potential to alter the pharmacokinetics of the drugs under study within 14 days of diagnosis and throughout the period of pharmacokinetic sampling; such agents include but are not limited to: grapefruit, tangelos or the juice of these fruits; St. Johns wort; anticonvulsants: carbamazepine, oxcarbazepine, phenytoin, phenobarbital, primidone; azole antifungal agents: ketoconazole, fluconazole, itraconazole, voriconazole; macrolide antibiotics: erythromycin, clarithromycin; isoniazid; rifampin; verapamil; and diltiazem
- Presence of known malabsorption syndrome
- Females with known pregnancy (pregnancy test must be negative to be eligible)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900445
| United States, Pennsylvania | |
| Childrens Oncology Group | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Ian Pollack | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00900445 |
| Other Study ID Numbers: |
ACCL0631 NCI-2011-02151 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000588173 ACCL0631 ( Other Identifier: Childrens Oncology Group ) COG-ACCL0631 ( Other Identifier: DCP ) ACCL0631 ( Other Identifier: CTEP ) U10CA095861 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 12, 2009 Key Record Dates |
| Last Update Posted: | August 7, 2018 |
| Last Verified: | March 2013 |
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate |
Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Cortisone Vincristine Daunorubicin Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |